Luteal PhaseNCT05089383
Vaginal Versus Combined Use of Progesterone in Fresh IVF/ICSI Cycles
An observational study of Luteal Phase, run by University of Athens at 1 site in Greece.
Trial summary
Hypothesis: the combined use of progesterone administration for luteal phase support is superior to the single route of progesterone administration in terms of pregnancy outcome parameters in women undergoing fresh IVF/ICSI cycles. Read more about this study
- Who is it for?
- Ages 22 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Luteal Phase
- What is being tested?
- Utrogestan
- Type of treatment
- Injection or infusion
- How many people
- 698 participants
- Where
- 1 siteGreece
- Study dates
- 14 Sep 2021to Dec 2023
- Phase
- Observational
- 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 22 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Infertile couples with an indication for IVF/ICSI (both Units).
Who may be able to join
- Patients with a documented history of infertility, aged 22-40, undergoing fresh embryo transfer after IVF/ICSI, under informed consent.
- Physiological menstrual cycles (24-35 days), normal endocrine function (FSH ≤ 15 IU / ml), transvaginal ultrasound without pathological findings, free personal medical history, indication for IVF/ICSI.
Who cannot join
- Endocrine or metabolic disorders, e.g., PCO (S), pathology of the uterus and/or endometrium, basal FSH levels> 15 IU / ml, major surgery in the ovaries (removal), and age <22 years and > 40 years old.
- Active pelvic inflammatory disease
- IVF/ICSI with donor eggs
- Previous participation in this trial
Trial locations and contacts
1 site in 1 country.
Nikolaos Vlachos contact
Greece1 site, 1 recruiting
- Recruiting
National and Kapodistrian University of Athens
Athens, Attica, 11528
Nikolaos Vlahos, Prof, nfvlahos@gmail.com
Vassiliki Dourou, Midwife, 6977706799 ext. 0030, vdourou@gmail.com
About this study
Hypothesis: the combined use of progesterone administration for luteal phase support is superior to the single route of progesterone administration in terms of pregnancy outcome parameters in women undergoing fresh IVF/ICSI cycles.
Read the detailed description
In ART (IVF/ICSI), most of the studies have shown a deficiency of progesterone during the luteal phase, especially due to the use of GnRH analogs. The lack of progesterone leads to abnormal endometrial development and consequently to desynchronization between the latter and the blastocyst implantation. Therefore, it is a standard of care to use progesterone for luteal phase support after embryo transfer and during the first trimester, in case of pregnancy.
According to ESHRE guidelines, either of vaginal, oral, subcutaneous or intramuscular route is advisable.
But, until now, there is no robust evidence on the effect on pregnancy outcome of the combined route of progesterone administration compared to the standard of care (single route).
The aim of this study is to compare the effectiveness of the combined route of progesterone administration to the single route.
The study is a prospective cohort study. Participants will receive either standard treatment with single route (vaginal) progesterone administration according to the ESHRE guidelines, or combination of more than one routes of administration, that is vaginal plus oral or subcutaneous progesterone, starting afterthe fresh embryo transfer until 12 weeks of gestation or a negative pregnancy test.
- Conditions
- Luteal Phase
- Being tested
- Utrogestan
- Keywords
- IVF, PROGESTERONE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UtrogestanDrug
Also called PROLUTEX,VASCLOR
PROSPECTIVE STUDY
| Study group | Role | What they receive |
|---|---|---|
| combined progesterone group | patients will receive vaginal plus subcutaneous or per os progesterone Receives: Drug: Utrogestan | |
| Vaginal progesterone group | patients will receive vaginal progesterone Receives: Drug: Utrogestan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate
The percentage of viable embryo after 20 weeks of gestation
Measured: 9 months]
Abortion rate
Loss of pregnancy up to 20 weeks of gestation
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start14 Sep 2021
- Primary completionFeb 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Luteal PhaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 698 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Collaborators
- Iaso Maternity Hospital, Athens, Greece
- Responsible party
- Principal investigator, Nikos Vlahos, University of Athens
- Investigators
- Nikolaos Vlachos, Study director, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05089383
- Sponsor's protocol ID
- ARETAIEION UNIVERSITY HOSPITAL
- Status last verified
- Oct 2021
- First submitted
- 10 Oct 2021
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
van der Linden M, Buckingham K, Farquhar C, Kremer JA, Metwally M. Luteal phase support for assisted reproduction cycles. Cochrane Database Syst Rev. 2015 Jul 7;2015(7):CD009154. doi: 10.1002/14651858.CD009154.pub3.
PubMed 26148507Practice Committee of the American Society for Reproductive Medicine. Progesterone supplementation during the luteal phase and in early pregnancy in the treatment of infertility: an educational bulletin. Fertil Steril. 2008 Apr;89(4):789-92. doi: 10.1016/j.fertnstert.2008.02.012.
PubMed 18406835Pabuccu E, Pabuccu R, Gurgan T, Tavmergen E. Luteal phase support in fresh and frozen embryo transfer cycles. J Gynecol Obstet Hum Reprod. 2020 Jun 22:101838. doi: 10.1016/j.jogoh.2020.101838. Online ahead of print.
PubMed 32585391Tournaye 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 28333318Baker VL, Jones CA, Doody K, Foulk R, Yee B, Adamson GD, Cometti B, DeVane G, Hubert G, Trevisan S, Hoehler F, Jones C, Soules M. A randomized, controlled trial comparing the efficacy and safety of aqueous subcutaneous progesterone with vaginal progesterone for luteal phase support of in vitro fertilization. Hum Reprod. 2014 Oct 10;29(10):2212-20. doi: 10.1093/humrep/deu194. Epub 2014 Aug 6.
PubMed 25100106Tomic V, Kasum M, Vucic K. The role of luteal support during IVF: a qualitative systematic review. Gynecol Endocrinol. 2019 Oct;35(10):829-834. doi: 10.1080/09513590.2019.1603288. Epub 2019 Apr 29.
PubMed 31032676Griesinger G, Blockeel C, Sukhikh GT, Patki A, Dhorepatil B, Yang DZ, Chen ZJ, Kahler E, Pexman-Fieth C, Tournaye H. Oral dydrogesterone versus intravaginal micronized progesterone gel for luteal phase support in IVF: a randomized clinical trial. Hum Reprod. 2018 Dec 1;33(12):2212-2221. doi: 10.1093/humrep/dey306.
PubMed 30304457
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Versus Combined Use of Progesterone in Fresh IVF/ICSI Cycles
- ClinicalTrials.gov ID
- NCT05089383
- Acronym / sponsor ID
- ARETAIEION UNIVERSITY HOSPITAL
- Conditions
- Luteal Phase
- Keywords
- IVF, PROGESTERONE
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 698 participants (estimated)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Collaborators
- Iaso Maternity Hospital, Athens, Greece
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 22 Oct 2021 (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.
Hypothesis: the combined use of progesterone administration for luteal phase support is superior to the single route of progesterone administration in terms of pregnancy outcome parameters in women undergoing fresh IVF/ICSI cycles.
Detailed description
In ART (IVF/ICSI), most of the studies have shown a deficiency of progesterone during the luteal phase, especially due to the use of GnRH analogs. The lack of progesterone leads to abnormal endometrial development and consequently to desynchronization between the latter and the blastocyst implantation. Therefore, it is a standard of care to use progesterone for luteal phase support after embryo transfer and during the first trimester, in case of pregnancy.
According to ESHRE guidelines, either of vaginal, oral, subcutaneous or intramuscular route is advisable.
But, until now, there is no robust evidence on the effect on pregnancy outcome of the combined route of progesterone administration compared to the standard of care (single route).
The aim of this study is to compare the effectiveness of the combined route of progesterone administration to the single route.
The study is a prospective cohort study. Participants will receive either standard treatment with single route (vaginal) progesterone administration according to the ESHRE guidelines, or combination of more than one routes of administration, that is vaginal plus oral or subcutaneous progesterone, starting afterthe fresh embryo transfer until 12 weeks of gestation or a negative pregnancy test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combined progesterone group | – | Drug: Utrogestanpatients will receive vaginal plus subcutaneous or per os progesterone |
| Vaginal progesterone group | – | Drug: Utrogestanpatients will receive vaginal progesterone |
Who may qualify
- Ages
- 22 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Infertile couples with an indication for IVF/ICSI (both Units).
Key inclusion criteria (2 listed)
- Patients with a documented history of infertility, aged 22-40, undergoing fresh embryo transfer after IVF/ICSI, under informed consent.
- Physiological menstrual cycles (24-35 days), normal endocrine function (FSH ≤ 15 IU / ml), transvaginal ultrasound without pathological findings, free personal medical history, indication for IVF/ICSI.
Key exclusion criteria (4 listed)
- Endocrine or metabolic disorders, e.g., PCO (S), pathology of the uterus and/or endometrium, basal FSH levels> 15 IU / ml, major surgery in the ovaries (removal), and age <22 years and > 40 years old.
- Active pelvic inflammatory disease
- IVF/ICSI with donor eggs
- Previous participation in this trial
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 |
|---|---|---|
| UtrogestanAlso: PROLUTEX,VASCLORPROSPECTIVE STUDY | Drug | Vaginal progesterone group, combined progesterone group |
Primary outcome
Live birth rate
Time frame: 9 months]
The percentage of viable embryo after 20 weeks of gestation
Abortion rate
Time frame: 20 weeks
Loss of pregnancy up to 20 weeks of gestation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Background: PubMed 26148507van der Linden M, Buckingham K, Farquhar C, Kremer JA, Metwally M. Luteal phase support for assisted reproduction cycles. Cochrane Database Syst Rev. 2015 Jul 7;2015(7):CD009154. doi: 10.1002/14651858.CD009154.pub3.
- Background: PubMed 18406835Practice Committee of the American Society for Reproductive Medicine. Progesterone supplementation during the luteal phase and in early pregnancy in the treatment of infertility: an educational bulletin. Fertil Steril. 2008 Apr;89(4):789-92. doi: 10.1016/j.fertnstert.2008.02.012.
- Background: PubMed 32585391Pabuccu E, Pabuccu R, Gurgan T, Tavmergen E. Luteal phase support in fresh and frozen embryo transfer cycles. J Gynecol Obstet Hum Reprod. 2020 Jun 22:101838. doi: 10.1016/j.jogoh.2020.101838. Online ahead of print.
- 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.
- Background: PubMed 25100106Baker VL, Jones CA, Doody K, Foulk R, Yee B, Adamson GD, Cometti B, DeVane G, Hubert G, Trevisan S, Hoehler F, Jones C, Soules M. A randomized, controlled trial comparing the efficacy and safety of aqueous subcutaneous progesterone with vaginal progesterone for luteal phase support of in vitro fertilization. Hum Reprod. 2014 Oct 10;29(10):2212-20. doi: 10.1093/humrep/deu194. Epub 2014 Aug 6.
- Background: PubMed 31032676Tomic V, Kasum M, Vucic K. The role of luteal support during IVF: a qualitative systematic review. Gynecol Endocrinol. 2019 Oct;35(10):829-834. doi: 10.1080/09513590.2019.1603288. Epub 2019 Apr 29.
- Background: PubMed 30304457Griesinger G, Blockeel C, Sukhikh GT, Patki A, Dhorepatil B, Yang DZ, Chen ZJ, Kahler E, Pexman-Fieth C, Tournaye H. Oral dydrogesterone versus intravaginal micronized progesterone gel for luteal phase support in IVF: a randomized clinical trial. Hum Reprod. 2018 Dec 1;33(12):2212-2221. doi: 10.1093/humrep/dey306.
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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.
Nikolaos Vlachos contact
Nikolaos Vlachos study director
National and Kapodistrian University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Luteal Phase, run by University of Athens at 1 site in Greece.
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 4 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 22 Oct 2021. 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 Greece. 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.
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 Vasiliki Dourou (+306977706799, vdourou@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth rate (time frame: 9 months]). The study lists 2 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 NCT05089383, which also lists 7 linked publications.
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 22 Oct 2021.