Infertility, FemalePhase 4NCT04124913
Oral Dydrogesterone vs. Micronized Vaginal Progesterone for Luteal Phase Support in Frozen-thawed Embryo Transfer Cycles
A Phase 4 study testing Dydrogesterone 10 MG Oral Tablet and Progesterone Vaginal Gel [Crinone] in people with Infertility, Female and Infertility, Male, run by Memorial Sisli Hospital, Istanbul at 1 site in Turkey (Türkiye).
Trial summary
The aim of this randomized controlled trial is to compare the efficacy of oral dydrogesterone vs. micronized vaginal progesterone for luteal phase support in frozen-thawed embryo transfer cycles. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female, Infertility, Male, Embryo Transfer
- What is being tested?
- Dydrogesterone 10 MG Oral Tablet and Progesterone Vaginal Gel [Crinone]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2019to Dec 2019
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages between 20 and 40
- Modified natural frozen- thawed embryo transfer cycles
Who cannot join
- Recurrent implantation failure
- Recurrent pregnancy loss
- Presence of uterine pathology
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Memorial Şişli Hospital
Istanbul, Şişli, 34385
Gonul Ozer, MD, +905326945549, drgonulozer@gmail.com
Kadriye B Yuksel, Assoc. Prof., +905438852666, berilyuksel@gmail.com
About this study
Official title: Comparison of Oral Dydrogesterone Versus Micronized Vaginal Progesterone for Luteal Phase Support in Frozen-thawed Embryo Transfer Cycles: a Randomized Controlled Trial
The aim of this randomized controlled trial is to compare the efficacy of oral dydrogesterone vs. micronized vaginal progesterone for luteal phase support in frozen-thawed embryo transfer cycles.
- Conditions
- Infertility, Female, Infertility, Male, Embryo Transfer, Fertilization in Vitro, Drug Effect, Reproductive Techniques, Assisted
- Being tested
- Dydrogesterone 10 MG Oral Tablet, Progesterone Vaginal Gel [Crinone]
- Keywords
- oral dydrogesterone, luteal phase support, vaginal progesterone gel, frozen-thawed embryo transfer
- Medical subject headings
- Infertility, Female, Infertility, Male, Helping Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dydrogesterone 10 MG Oral TabletDrug
Also called Duphaston
Oral dydrogesterone 10 mg tablet three times a day for luteal phase support
Progesterone Vaginal Gel [Crinone]Drug
Also called Crinone %8 vaginal progesterone gel
Vaginal progesterone gel 90 mg once a day for luteal phase support
| Study group | Role | What they receive |
|---|---|---|
| Dydrogesterone | Experimental | Not described Receives: Drug: Dydrogesterone 10 MG Oral Tablet |
| Vaginal progesterone | Active comparator | Not described Receives: Drug: Progesterone Vaginal Gel [Crinone] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate
Presence of at least one live fetus at the end of the 12th gestational week
Measured: 12 weeks after the last menstrual period of the patient
Secondary outcomes (17)
Clinical pregnancy rate
Presence of an intrauterine gestational sac with fetal heart beat at 7th week of gestation
Measured: 6-7 weeks after the last menstrual period of the patient
Implantation rate
Percentage of gestational sacs compared to the number of embryos transferred
Measured: 5 weeks after the last menstrual period of the patient
Biochemical pregnancy
Positive serum beta HCG test performed 10 days after embryo transfer
Measured: 10 days after embryo transfer
Biochemical miscarriage
pregnancy loss before ultrasonographic detection of an intrauterine gestational sac
Measured: before 5th gestational week
Clinical miscarriage
pregnancy loss after ultrasonographic detection of an intrauterine gestational sac
Measured: after 5th gestational week
headache rate
Measured: 6-7 weeks after the last menstrual period of the patient
interference with coitus rate
Measured: 6-7 weeks after the last menstrual period of the patient
somnolence rate
Measured: 6-7 weeks after the last menstrual period of the patient
dizziness rate
Measured: 6-7 weeks after the last menstrual period of the patient
nausea/vomiting rate
Measured: 6-7 weeks after the last menstrual period of the patient
vaginal discharge rate
Measured: 6-7 weeks after the last menstrual period of the patient
perineal irritation rate
Measured: 6-7 weeks after the last menstrual period of the patient
abdominal pain rate
Measured: 6-7 weeks after the last menstrual period of the patient
mastalgia rate
Measured: 6-7 weeks after the last menstrual period of the patient
vaginal bleeding rate
Measured: 6-7 weeks after the last menstrual period of the patient
interference with intercourse rate
Measured: 6-7 weeks after the last menstrual period of the patient
overall satisfaction score
patient satisfaction from the drug used measured on a 1-5 scale
Measured: 6-7 weeks after the last menstrual period of the patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2019
- Study start2 Jan 2019
- Primary completionOct 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sisli Hospital, Istanbul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gönül Özer, Memorial Sisli Hospital, Istanbul
- Investigators
- Semra Kahraman, Prof, Principal investigator, Memorial Şişli Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04124913
- Sponsor's protocol ID
- 2019/001
- Status last verified
- Oct 2019
- First submitted
- 10 Oct 2019
- Last updated
- 14 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Oral Dydrogesterone Versus Micronized Vaginal Progesterone for Luteal Phase Support in Frozen-thawed Embryo Transfer Cycles: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04124913
- Acronym / sponsor ID
- 2019/001
- Conditions
- Infertility, Female, Infertility, Male, Embryo Transfer, Fertilization in Vitro, Drug Effect, Reproductive Techniques, Assisted
- Keywords
- oral dydrogesterone, luteal phase support, vaginal progesterone gel, frozen-thawed embryo transfer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Memorial Sisli Hospital, IstanbulUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 14 Oct 2019 (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.
The aim of this randomized controlled trial is to compare the efficacy of oral dydrogesterone vs. micronized vaginal progesterone for luteal phase support in frozen-thawed embryo transfer cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Dydrogesterone | Experimental | Drug: Dydrogesterone 10 MG Oral Tablet |
| Vaginal progesterone | Active comparator | Drug: Progesterone Vaginal Gel [Crinone] |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Ages between 20 and 40
- Modified natural frozen- thawed embryo transfer cycles
Key exclusion criteria (3 listed)
- Recurrent implantation failure
- Recurrent pregnancy loss
- Presence of uterine pathology
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 10 MG Oral TabletAlso: DuphastonOral dydrogesterone 10 mg tablet three times a day for luteal phase support | Drug | Dydrogesterone |
| Progesterone Vaginal Gel [Crinone]Also: Crinone %8 vaginal progesterone gelVaginal progesterone gel 90 mg once a day for luteal phase support | Drug | Vaginal progesterone |
Primary outcome
Ongoing pregnancy rate
Time frame: 12 weeks after the last menstrual period of the patient
Presence of at least one live fetus at the end of the 12th gestational week
17 secondary outcomes
Clinical pregnancy rate
Time frame: 6-7 weeks after the last menstrual period of the patient
Implantation rate
Time frame: 5 weeks after the last menstrual period of the patient
Biochemical pregnancy
Time frame: 10 days after embryo transfer
Biochemical miscarriage
Time frame: before 5th gestational week
Clinical miscarriage
Time frame: after 5th gestational week
headache rate
Time frame: 6-7 weeks after the last menstrual period of the patient
interference with coitus rate
Time frame: 6-7 weeks after the last menstrual period of the patient
somnolence rate
Time frame: 6-7 weeks after the last menstrual period of the patient
dizziness rate
Time frame: 6-7 weeks after the last menstrual period of the patient
nausea/vomiting rate
Time frame: 6-7 weeks after the last menstrual period of the patient
vaginal discharge rate
Time frame: 6-7 weeks after the last menstrual period of the patient
perineal irritation rate
Time frame: 6-7 weeks after the last menstrual period of the patient
abdominal pain rate
Time frame: 6-7 weeks after the last menstrual period of the patient
mastalgia rate
Time frame: 6-7 weeks after the last menstrual period of the patient
vaginal bleeding rate
Time frame: 6-7 weeks after the last menstrual period of the patient
interference with intercourse rate
Time frame: 6-7 weeks after the last menstrual period of the patient
overall satisfaction score
Time frame: 6-7 weeks after the last menstrual period of the patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2019.
Related trials for Infertility, Female
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingPhase 2
A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
Functional Hypothalamic Amenorrhea, FHA
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
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.
Semra Kahraman, Prof principal investigator
Memorial Şişli Hospital
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 10 MG Oral Tablet and Progesterone Vaginal Gel [Crinone] in people with Infertility, Female and Infertility, Male, run by Memorial Sisli Hospital, Istanbul at 1 site in Turkey (Türkiye).
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 14 Oct 2019. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gonul Ozer, MD (+905326945549, drgonulozer@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing pregnancy rate (time frame: 12 weeks after the last menstrual period of the patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2019.