Infertility, FemalePhase 4NCT03677336

Oral Dydrogesterone (OD) Versus Micronized Vaginal Progesterone (MVP) for Luteal Phase Support (LPS) in IVF/ICSI

A Phase 4 study testing Dydrogesterone Oral Tablet and Micronized progesterone in people with Infertility, Female and Infertility, run by CRG UZ Brussel at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for: Infertility, Female, Infertility, Genital Diseases, Male
What is being tested?: Dydrogesterone Oral Tablet and Micronized progesterone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 1 siteBelgium
Study dates: 1 May 2019to 24 Aug 2020
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 35 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Oocyte donor candidates
Regularly cycling
BMI ≥18 and ≤ 29 kg/m2
Signed informed consent
Non-smokers.
AMH <7,53 and >1,18 ng/mL (90th and 10th percentile for healthy women aged 25-29 according to the used Elecsys® AMH kit by Roche)
PRL, T and TSH within the normal limits for the clinical laboratory, or considered not clinically significant by the investigator within 6 months prior or at screening

Who cannot join

Intra-uterine device
Previous enrollment
Evidence of cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatologic/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurologic/psychiatric, allergy, recent major surgery (< 3 months), or other relevant diseases as revealed by history, physical examination and/or laboratory assessments which could limit participation in or completion of the study
Acute urogenital disease during the course of the study
Known allergic reactions to progesterone / dydrogesterone products (active substance or to any of the excipients)
Intake of any experimental drug or any participation in any other clinical trial within 30 days prior to study start.

Show all 11Show fewer

Mental disability or any other lack of fitness, in the investigator's opinion, to preclude subjects in or to complete the study.
Current or recent substance abuse, including alcohol and tobacco (patients who stopped tobacco usage at least 3 months prior to screening visit would be allowed)
Refusal or inability to comply with the requirements of the study protocol for any reason, including scheduled clinic visits and laboratory tests.
Known or suspected progestogen dependent neoplasms (e.g. meningioma)
Serum progesterone level >1.5 ng/mL at ovulation triggering

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Centrum voor Reproductieve Geneeskunde
Jette, Brussels Capital, 1090

Other trials in Belgium

About this study

Official title: Oral Dydrogesterone Versus Micronized Vaginal Progesterone for Luteal Phase Support in In Vitro Fertilisation (IVF)/ IntraCytoplasmic Sperm Injection (ICSI): Pharmacokinetics and the Impact on the Endometrium, the Microbiota of the Genital Tract and the Peripheral Immunology. Double Blind Crossover Study.

Female inability to conceive a child. The purpose of this prospective randomized, double-blinded, double dummy, two-arm cross-over study is to investigate the difference on histological, transcriptional and immunological level in endometrium between 3x10mg Dydrogesterone oral tablets and 3x200 mg Micronized progesterone intravaginal capsules for the luteal support in egg cell donors. Beside that, the pharmacokinetics, the impact on the peripheral immunology (by blood sampling) and the microbiota (by genital swabs) will be investigated.

Conditions: Infertility, Female, Infertility, Genital Diseases, Male, Genital Diseases, Female, Progesterone, Dydrogesterone
Being tested: Dydrogesterone Oral Tablet, Micronized progesterone, Placebo Dydrogesterone oral tablet, Placebo Micronized progesterone
Medical subject headings: Infertility, Female, Infertility, Genital Diseases, Male, Genital Diseases, Female

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dydrogesterone Oral TabletDrug
Also called OD, Duphaston
Tablet, oral, 10 mg, 3 times daily, starting on the day of oocyte retrieval in the morning and during 8 days
Micronized progesteroneDrug
Also called MVP, Utrogestan
Capsule, vaginal, 200 mg, 3 times daily, starting on the day of oocyte retrieval in the morning and during 8 days
Placebo Dydrogesterone oral tabletDrug
Also called Placebo OD
Tablet, indistinguishable from dydrogesterone oral tablet
Placebo Micronized progesteroneDrug
Also called Placebo MVP
Capsule, indistinguishable from micronized vaginal progesterone capsules

Study groups in NCT03677336
Study group	Role	What they receive
Group l: 1st cycle MVP/placebo OD	Other	2 cycles of controlled ovarian stimulation, dual triggering, oocyte retrieval (OR) and LPS, with an interval period of 2 to 12 months. The only difference of the second cycle being the other LPS study medication as compared to the first cycle. * 1st cycle: Start on day of oocyte retrieval (OR) (=d1): Dydrogesterone Oral Tablet 10 mg 3 times daily + Placebo micronized vaginal progesterone 200 mg capsules 3 times daily, for 8 days. * 2nd cycle: Start on day of oocyte retrieval (OR) (=day 1): 'Micronized Progesterone 200 mg intravaginal capsules 3 times daily + placebo 'Dydrogesterone Oral Tablet 10 mg 3 times daily, for 8 days. Receives: Drug: Dydrogesterone Oral Tablet; Drug: Micronized progesterone; Drug: Placebo Dydrogesterone oral tablet; Drug: Placebo Micronized progesterone
Group ll: 1st cycle placebo MVP/OD	Other	2 cycles of controlled ovarian stimulation, dual triggering, oocyte retrieval (OR) and LPS, with an interval period of 2 to 12 months. The only difference of the second cycle being the other LPS study medication as compared to the first cycle. * 1st cycle: Start on day of oocyte retrieval (OR) (=day 1): Micronized Progesterone 200 mg intravaginal capsules 3 times daily + placebo Dydrogesterone Oral Tablet 10 mg 3 times daily, for 8 days. * 2nd cycle: Start on day of oocyte retrieval (OR) (=day 1): Dydrogesterone Oral Tablet 10 mg 3 times daily + Placebo micronized progesterone 200 mg intravaginal capsules 3 times daily, for 8 days. Receives: Drug: Dydrogesterone Oral Tablet; Drug: Micronized progesterone; Drug: Placebo Dydrogesterone oral tablet; Drug: Placebo Micronized progesterone

What is being measured

The primary outcome is the main question the study is designed to answer.

Molecular endometrial level using illumina RNA-seq
To study the difference of OD versus MVP as LPS after controlled ovarian stimulation (COS) on the molecular endometrial level using Illumina RNA-seq on endometrial derived single cell suspensions
Measured: On the eight day (at 8am) of LPS intake
Molecular endometrial level using immunohistochemistry
To study the difference of OD versus MVP as LPS after controlled ovarian stimulation (COS) on the molecular endometrial level using immunohistochemistry on endometrial derived single cell suspensions
Measured: On the eight day (at 8am) of LPS intake
Molecular endometrial level using flow cytometry
To study the difference of OD versus MVP as LPS after controlled ovarian stimulation (COS) on the molecular endometrial level using flow cytometry on endometrial derived single cell suspensions
Measured: On the eight day (at 8am) of LPS intake

Secondary outcomes (23)

Difference in pharmacokinetic profile: Progesterone: AUC0-τ
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Measured: On the first and eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Difference in pharmacokinetic profile: Progesterone: AUC0-t
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Measured: On the first day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose.
Difference in pharmacokinetic profile: Progesterone: Cmax
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Measured: On the first and eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Difference in pharmacokinetic profile: Progesterone: tmax
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Measured: On the first and eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Difference in pharmacokinetic profile: Progesterone: Ctrough
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Measured: On the eight day of LPS intake: 1 hour before morning dose.
Difference in pharmacokinetic profile: Progesterone: λz
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Measured: On the eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Difference in pharmacokinetic profile: Progesterone: t1/2
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Measured: On the eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Difference in pharmacokinetic profile: Progesterone: CL/F
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Measured: On the eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Difference in pharmacokinetic profile: Progesterone: Vz/F
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Measured: On the eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: AUC0-τ
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Measured: On the first and eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: ratios of AUC0-τ of dydrogesterone and DHD
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Measured: On the first and eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: AUC0-t
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Measured: On the first day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose.
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: ratios of AUC0-t of dydrogesterone and DHD
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Measured: On the first day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose.
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: Cmax
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Measured: On the first and eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: ratios of Cmax of dydrogesterone and DHD
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Measured: On the first and eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: tmax
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Measured: On the first and eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: Ctrough
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Measured: On the eight day of LPS intake: 1 hour before morning dose.
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: λz
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Measured: On the eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: t1/2
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Measured: On the eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: CL/F
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Measured: On the eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: Vz/F
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Measured: On the eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Difference in peripheral immunology
To study the effects of OD versus MVP on the peripheral immunology (using flow cytometry to investigate T regulatory and T effector cells derived from peripheral blood)
Measured: On the first and eight day of LPS intake, 1hour before morning dose at 9 am.
Difference in microbiota in the female genital tract
by cervical swab, a vaginal swab (posterior fornix) and an intra-uterine sample using an empty embryo catheter. Evaluation using 16S rRNA amplicon sequencing - Illumina miSeq
Measured: On the first and eight day of LPS intake, 1 hour before morning dose at 9 am.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 201924 Aug 2020

First posted19 Sep 2018
Study start1 May 2019
Primary completion24 Aug 2020
Study completion24 Aug 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Infertility, FemaleStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: A randomised, cross-over, double blind double dummy study
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03677336
Sponsor's protocol ID: DYDRA001
Other IDs: 2018-000105-23, 2018
Status last verified: Dec 2020
First submitted: 4 Sep 2018
Last updated: 17 Dec 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Tournaye H, Sukhikh GT, Kahler E, Griesinger G. A Phase III randomized controlled trial comparing the efficacy, safety and tolerability of oral dydrogesterone versus micronized vaginal progesterone for luteal support in in vitro fertilization. Hum Reprod. 2017 May 1;32(5):1019-1027. doi: 10.1093/humrep/dex023.
PubMed 28333318

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Oral Dydrogesterone Versus Micronized Vaginal Progesterone for Luteal Phase Support in In Vitro Fertilisation (IVF)/ IntraCytoplasmic Sperm Injection (ICSI): Pharmacokinetics and the Impact on the Endometrium, the Microbiota of the Genital Tract and the Peripheral Immunology. Double Blind Crossover Study.
ClinicalTrials.gov ID: NCT03677336
Acronym / sponsor ID: DYDRA001
Conditions: Infertility, Female, Infertility, Genital Diseases, Male, Genital Diseases, Female, Progesterone, Dydrogesterone
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: CRG UZ BrusselUniversity, hospital or other
Collaborators: Universitätsklinikum Hamburg-Eppendorf, Abbott, KU Leuven
Study start: 1 May 2019 (actual)
Primary completion: 24 Aug 2020 (actual)
Study completion: 24 Aug 2020 (actual)
First posted: 19 Sep 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: A randomised, cross-over, double blind double dummy study

Arm	Type	Receives
Group l: 1st cycle MVP/placebo OD	Other	Drug: Dydrogesterone Oral Tablet, Drug: Micronized progesterone, Drug: Placebo Dydrogesterone oral tablet, Drug: Placebo Micronized progesterone2 cycles of controlled ovarian stimulation, dual triggering, oocyte retrieval (OR) and LPS, with an interval period of 2 to 12 months. The only difference of the second cycle being the other LPS study medication as compared to the first cycle. * 1st cycle: Start on day of oocyte retrieval (OR) (=d1): Dydrogesterone Oral Tablet 10 mg 3 times daily + Placebo micronized vaginal progesterone 200 mg capsules 3 times daily, for 8 days. * 2nd cycle: Start on day of oocyte retrieval (OR) (=day 1): 'Micronized Progesterone 200 mg intravaginal capsules 3 times daily + placebo 'Dydrogesterone Oral Tablet 10 mg 3 times daily, for 8 days.
Group ll: 1st cycle placebo MVP/OD	Other	Drug: Dydrogesterone Oral Tablet, Drug: Micronized progesterone, Drug: Placebo Dydrogesterone oral tablet, Drug: Placebo Micronized progesterone2 cycles of controlled ovarian stimulation, dual triggering, oocyte retrieval (OR) and LPS, with an interval period of 2 to 12 months. The only difference of the second cycle being the other LPS study medication as compared to the first cycle. * 1st cycle: Start on day of oocyte retrieval (OR) (=day 1): Micronized Progesterone 200 mg intravaginal capsules 3 times daily + placebo Dydrogesterone Oral Tablet 10 mg 3 times daily, for 8 days. * 2nd cycle: Start on day of oocyte retrieval (OR) (=day 1): Dydrogesterone Oral Tablet 10 mg 3 times daily + Placebo micronized progesterone 200 mg intravaginal capsules 3 times daily, for 8 days.

Who may qualify

Ages: 18 to 35 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Oocyte donor candidates
Regularly cycling
BMI ≥18 and ≤ 29 kg/m2
Signed informed consent
Non-smokers.

Key exclusion criteria (11 listed)

Intra-uterine device
Previous enrollment
Evidence of cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatologic/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurologic/psychiatric, allergy, recent major surgery (< 3 months), or other relevant diseases as revealed by history, physical examination and/or laboratory assessments which could limit participation in or completion of the study
Acute urogenital disease during the course of the study
Known allergic reactions to progesterone / dydrogesterone products (active substance or to any of the excipients)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dydrogesterone Oral TabletAlso: OD, DuphastonTablet, oral, 10 mg, 3 times daily, starting on the day of oocyte retrieval in the morning and during 8 days	Drug	Group l: 1st cycle MVP/placebo OD, Group ll: 1st cycle placebo MVP/OD
Micronized progesteroneAlso: MVP, UtrogestanCapsule, vaginal, 200 mg, 3 times daily, starting on the day of oocyte retrieval in the morning and during 8 days	Drug	Group l: 1st cycle MVP/placebo OD, Group ll: 1st cycle placebo MVP/OD
Placebo Dydrogesterone oral tabletAlso: Placebo ODTablet, indistinguishable from dydrogesterone oral tablet	Drug	Group l: 1st cycle MVP/placebo OD, Group ll: 1st cycle placebo MVP/OD
Placebo Micronized progesteroneAlso: Placebo MVPCapsule, indistinguishable from micronized vaginal progesterone capsules	Drug	Group l: 1st cycle MVP/placebo OD, Group ll: 1st cycle placebo MVP/OD

Primary outcome

Molecular endometrial level using illumina RNA-seq
Time frame: On the eight day (at 8am) of LPS intake
To study the difference of OD versus MVP as LPS after controlled ovarian stimulation (COS) on the molecular endometrial level using Illumina RNA-seq on endometrial derived single cell suspensions
Molecular endometrial level using immunohistochemistry
Time frame: On the eight day (at 8am) of LPS intake
To study the difference of OD versus MVP as LPS after controlled ovarian stimulation (COS) on the molecular endometrial level using immunohistochemistry on endometrial derived single cell suspensions
Molecular endometrial level using flow cytometry
Time frame: On the eight day (at 8am) of LPS intake
To study the difference of OD versus MVP as LPS after controlled ovarian stimulation (COS) on the molecular endometrial level using flow cytometry on endometrial derived single cell suspensions

23 secondary outcomes

Difference in pharmacokinetic profile: Progesterone: AUC0-τ
Time frame: On the first and eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Difference in pharmacokinetic profile: Progesterone: AUC0-t
Time frame: On the first day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose.
Difference in pharmacokinetic profile: Progesterone: Cmax
Time frame: On the first and eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Difference in pharmacokinetic profile: Progesterone: tmax
Time frame: On the first and eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Difference in pharmacokinetic profile: Progesterone: Ctrough
Time frame: On the eight day of LPS intake: 1 hour before morning dose.
Difference in pharmacokinetic profile: Progesterone: λz
Time frame: On the eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Difference in pharmacokinetic profile: Progesterone: t1/2
Time frame: On the eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Difference in pharmacokinetic profile: Progesterone: CL/F
Time frame: On the eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Difference in pharmacokinetic profile: Progesterone: Vz/F
Time frame: On the eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: AUC0-τ
Time frame: On the first and eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: ratios of AUC0-τ of dydrogesterone and DHD
Time frame: On the first and eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: AUC0-t
Time frame: On the first day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose.
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: ratios of AUC0-t of dydrogesterone and DHD
Time frame: On the first day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose.
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: Cmax
Time frame: On the first and eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: ratios of Cmax of dydrogesterone and DHD
Time frame: On the first and eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: tmax
Time frame: On the first and eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: Ctrough
Time frame: On the eight day of LPS intake: 1 hour before morning dose.
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: λz
Time frame: On the eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: t1/2
Time frame: On the eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: CL/F
Time frame: On the eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: Vz/F
Time frame: On the eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Difference in peripheral immunology
Time frame: On the first and eight day of LPS intake, 1hour before morning dose at 9 am.
Difference in microbiota in the female genital tract
Time frame: On the first and eight day of LPS intake, 1 hour before morning dose at 9 am.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
Background: PubMed 28333318Tournaye H, Sukhikh GT, Kahler E, Griesinger G. A Phase III randomized controlled trial comparing the efficacy, safety and tolerability of oral dydrogesterone versus micronized vaginal progesterone for luteal support in in vitro fertilization. Hum Reprod. 2017 May 1;32(5):1019-1027. doi: 10.1093/humrep/dex023.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Herman Tournaye, PhD, MD principal investigator

Head of department CRG

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dydrogesterone Oral Tablet and Micronized progesterone in people with Infertility, Female and Infertility, run by CRG UZ Brussel at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Molecular endometrial level using illumina RNA-seq (time frame: On the eight day (at 8am) of LPS intake). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03677336, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.