InfertilityNCT05767086
Comparison of 3 Different Protocols for Preventing Premature Ovulation in Ovarian Stimulation Cycles
A study testing Gonadotropin releasing hormone antagonist (Cetrotide), Medroxyprogesterone Acetate (Tarlusal) and Dydrogesterone in people with Infertility, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
The aim of study is to evaluate the results of three different protocols for prevention of premature ovulation in ovarian stimulation cycles. All patients that undergo IVF cycles are randomly divided into three groups. Read more about this study
- Who is it for?
- Ages 20 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Gonadotropin releasing hormone antagonist (Cetrotide), Medroxyprogesterone Acetate (Tarlusal) and Dydrogesterone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 297 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2023to 30 Sep 2024
- Phase
- Interventional
- 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 38 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 20-38 years who applied to the infertility clinic
- BMI<25 kg/m2
- AMH>1 ng/mL
Who cannot join
- Adenomyosis
- Endometriosis
- Untreated uterine pathology
- Hormonal therapy in the last 3 months
- Contraindication for ovulation stimulation
- BMI>25 kg/m2
- AMH<1 ng/mL
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Cetrorelix, Medroxyprogesterone Acetate and Dydrogesterone for Preventing Premature Ovulation in Ovarian Stimulation Cycles
The aim of study is to evaluate the results of three different protocols for prevention of premature ovulation in ovarian stimulation cycles. All patients that undergo IVF cycles are randomly divided into three groups. The first group is cetrorelix, the second group is medroxyprogesterone acetate and the third group is dydrogesterone.
Read the detailed description
Approximately %10-15 of couples of reproductive age have infertility issues. Ovulation induction and in vitro fertilization (IVF) are the main treatments for infertility. With ovarian stimulation (OS), the efficiency of IVF has been increased by collecting more than one oocytes and thus providing more embryos. Multifollicular growth in OS may cause an increase in sex steroids and an early LH peak, thus premature ovulation. Pituitary suppression with certain drugs has been used to prevent premature ovulation.. Among these drugs, it has been observed that GnRH agonists can cause down-regulation, hypo-estrogenic symptoms, ovarian cyst formation and Ovarian Hyperstimulation Syndrome (OHSS), while antagonists may have side effects such as low oocyte count and high cycle cancellation. The use of progesterone preparations as an alternative to these drugs recently gained ground.
Data including age, BMI, the duration of infertility, the type of infertility, antral follicle count, serum day 3 FSH level, Serum anti-Müllerian hormone level, total gonadotropin dose, stimulation time, pituitary suppression starting day, duration of pituitary suppression, premature ovulation, number of total oocyte count, the number of total M2, the number of PN , the number of Day 5 blast, number of transferred embryos, endometrial thickness on the day of transfer will be recorded. When the follicle size reaches 13-14 mm, patients will be randomized into 3 groups. Group 1 (Cetrorelix: n=99, 0.25 mg/day subcutaneously), Group 2 (Medroxyprogesterone Acetate: n=99, 2x5mg/day orally) and Group 3 (Dydrogesterone: n=99, 3x10 mg/day orally). Human chorionic gonadotropin (hCG) will be used for trigger when at least 2 follicles' diameter reaches 17-18mm for ovulation. Thirty-six hours after the hCG injection, the patient's oocytes will be collected. During 2-5 days of embryo culture, embryo quality will be determined according to D.Gardner criteria (1999). Embryos will be frozen as blast on the 5th day and transferred to the frozen cycle to be planned within the next month. Clinical pregnancy rates will be recorded by performing a blood test for on the 12th day after the procedure.
The aim of this study is to evaluate the results of three different protocols for prevention of premature ovulation in ovarian stimulation cycles. All patients undergo IVF cycles are randomly divided in to three groups. The first group is cetrorelix, the second group is medroxyprogesterone acetate and the third group is dydrogesterone.
- Conditions
- Infertility
- Being tested
- Gonadotropin releasing hormone antagonist (Cetrotide), Medroxyprogesterone Acetate (Tarlusal), Dydrogesterone
- Keywords
- ovulation induction, IVF
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gonadotropin releasing hormone antagonist (Cetrotide)Drug
Also called Cetrotide
clinical pregnancy rates
Medroxyprogesterone Acetate (Tarlusal)Drug
Also called Tarlusal
clinical pregnancy rates
DydrogesteroneDrug
Also called Duphaston (Duphaston)
clinical pregnancy rates
| Study group | Role | What they receive |
|---|---|---|
| Gonadotropin-releasing hormone (GnRH) antagonist | Experimental | Cetrotide® (0.25 mg, MerckSerono Pharmaceuticals, Darmstadt, Germany) Receives: Drug: Gonadotropin releasing hormone antagonist (Cetrotide) |
| Medroxyprogesterone acetate | Experimental | Tarlusal® (5 mg, Deva Pharma, Istanbul, Turkey) Receives: Drug: Medroxyprogesterone Acetate (Tarlusal) |
| Dydrogesterone | Experimental | Duphaston® (10mg, Abbott Laboratories, Chicago, Illinois, ABD) Receives: Drug: Dydrogesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of clinical pregnancy
fetal heartbeat by transvaginal ultrasound
Measured: 4-5 weeks after IVF
Secondary outcomes (1)
Rate of ongoing pregnancy
Ongoing pregnancy rates 3 months after IVF
Measured: Months 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start15 Mar 2023
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 297 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05767086
- Sponsor's protocol ID
- 30.01.2023-E.94828
- Status last verified
- Oct 2024
- First submitted
- 27 Feb 2023
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ata B, Capuzzo M, Turkgeldi E, Yildiz S, La Marca A. Progestins for pituitary suppression during ovarian stimulation for ART: a comprehensive and systematic review including meta-analyses. Hum Reprod Update. 2021 Jan 4;27(1):48-66. doi: 10.1093/humupd/dmaa040.
PubMed 33016316Yildiz S, Turkgeldi E, Angun B, Eraslan A, Urman B, Ata B. Comparison of a novel flexible progestin primed ovarian stimulation protocol and the flexible gonadotropin-releasing hormone antagonist protocol for assisted reproductive technology. Fertil Steril. 2019 Oct;112(4):677-683. doi: 10.1016/j.fertnstert.2019.06.009. Epub 2019 Jul 29.
PubMed 31371053Alexandru P, Cekic SG, Yildiz S, Turkgeldi E, Ata B. Progestins versus GnRH analogues for pituitary suppression during ovarian stimulation for assisted reproductive technology: a systematic review and meta-analysis. Reprod Biomed Online. 2020 Jun;40(6):894-903. doi: 10.1016/j.rbmo.2020.01.027. Epub 2020 Feb 5.
PubMed 32327297Yang L, Luo K, Lu G, Lin G, Gong F. Euploidy rates among preimplantation genetic testing for aneuploidy cycles with oral dydrogesterone primed ovarian stimulation or GnRH antagonist protocol. Reprod Biomed Online. 2022 Oct;45(4):721-726. doi: 10.1016/j.rbmo.2022.03.003. Epub 2022 Mar 8.
PubMed 35989167La Marca A, Capuzzo M, Sacchi S, Imbrogno MG, Spinella F, Varricchio MT, Minasi MG, Greco P, Fiorentino F, Greco E. Comparison of euploidy rates of blastocysts in women treated with progestins or GnRH antagonist to prevent the luteinizing hormone surge during ovarian stimulation. Hum Reprod. 2020 Jun 1;35(6):1325-1331. doi: 10.1093/humrep/deaa068.
PubMed 32395749Begueria R, Garcia D, Vassena R, Rodriguez A. Medroxyprogesterone acetate versus ganirelix in oocyte donation: a randomized controlled trial. Hum Reprod. 2019 May 1;34(5):872-880. doi: 10.1093/humrep/dez034.
PubMed 30927417
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cetrorelix, Medroxyprogesterone Acetate and Dydrogesterone for Preventing Premature Ovulation in Ovarian Stimulation Cycles
- ClinicalTrials.gov ID
- NCT05767086
- Acronym / sponsor ID
- 30.01.2023-E.94828
- Conditions
- Infertility
- Keywords
- ovulation induction, IVF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 297 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 14 Mar 2023 (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 study is to evaluate the results of three different protocols for prevention of premature ovulation in ovarian stimulation cycles. All patients that undergo IVF cycles are randomly divided into three groups. The first group is cetrorelix, the second group is medroxyprogesterone acetate and the third group is dydrogesterone.
Detailed description
Approximately %10-15 of couples of reproductive age have infertility issues. Ovulation induction and in vitro fertilization (IVF) are the main treatments for infertility. With ovarian stimulation (OS), the efficiency of IVF has been increased by collecting more than one oocytes and thus providing more embryos. Multifollicular growth in OS may cause an increase in sex steroids and an early LH peak, thus premature ovulation. Pituitary suppression with certain drugs has been used to prevent premature ovulation.. Among these drugs, it has been observed that GnRH agonists can cause down-regulation, hypo-estrogenic symptoms, ovarian cyst formation and Ovarian Hyperstimulation Syndrome (OHSS), while antagonists may have side effects such as low oocyte count and high cycle cancellation. The use of progesterone preparations as an alternative to these drugs recently gained ground.
Data including age, BMI, the duration of infertility, the type of infertility, antral follicle count, serum day 3 FSH level, Serum anti-Müllerian hormone level, total gonadotropin dose, stimulation time, pituitary suppression starting day, duration of pituitary suppression, premature ovulation, number of total oocyte count, the number of total M2, the number of PN , the number of Day 5 blast, number of transferred embryos, endometrial thickness on the day of transfer will be recorded. When the follicle size reaches 13-14 mm, patients will be randomized into 3 groups. Group 1 (Cetrorelix: n=99, 0.25 mg/day subcutaneously), Group 2 (Medroxyprogesterone Acetate: n=99, 2x5mg/day orally) and Group 3 (Dydrogesterone: n=99, 3x10 mg/day orally). Human chorionic gonadotropin (hCG) will be used for trigger when at least 2 follicles' diameter reaches 17-18mm for ovulation. Thirty-six hours after the hCG injection, the patient's oocytes will be collected. During 2-5 days of embryo culture, embryo quality will be determined according to D.Gardner criteria (1999). Embryos will be frozen as blast on the 5th day and transferred to the frozen cycle to be planned within the next month. Clinical pregnancy rates will be recorded by performing a blood test for on the 12th day after the procedure.
The aim of this study is to evaluate the results of three different protocols for prevention of premature ovulation in ovarian stimulation cycles. All patients undergo IVF cycles are randomly divided in to three groups. The first group is cetrorelix, the second group is medroxyprogesterone acetate and the third group is dydrogesterone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gonadotropin-releasing hormone (GnRH) antagonist | Experimental | Drug: Gonadotropin releasing hormone antagonist (Cetrotide)Cetrotide® (0.25 mg, MerckSerono Pharmaceuticals, Darmstadt, Germany) |
| Medroxyprogesterone acetate | Experimental | Drug: Medroxyprogesterone Acetate (Tarlusal)Tarlusal® (5 mg, Deva Pharma, Istanbul, Turkey) |
| Dydrogesterone | Experimental | Drug: DydrogesteroneDuphaston® (10mg, Abbott Laboratories, Chicago, Illinois, ABD) |
Who may qualify
- Ages
- 20 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women aged 20-38 years who applied to the infertility clinic
- BMI<25 kg/m2
- AMH>1 ng/mL
Key exclusion criteria (7 listed)
- Adenomyosis
- Endometriosis
- Untreated uterine pathology
- Hormonal therapy in the last 3 months
- Contraindication for ovulation stimulation
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 |
|---|---|---|
| Gonadotropin releasing hormone antagonist (Cetrotide)Also: Cetrotideclinical pregnancy rates | Drug | Gonadotropin-releasing hormone (GnRH) antagonist |
| Medroxyprogesterone Acetate (Tarlusal)Also: Tarlusalclinical pregnancy rates | Drug | Medroxyprogesterone acetate |
| DydrogesteroneAlso: Duphaston (Duphaston)clinical pregnancy rates | Drug | Dydrogesterone |
Primary outcome
Rate of clinical pregnancy
Time frame: 4-5 weeks after IVF
fetal heartbeat by transvaginal ultrasound
1 secondary outcome
Rate of ongoing pregnancy
Time frame: Months 3
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 15 Oct 2024.
- Background: PubMed 33016316Ata B, Capuzzo M, Turkgeldi E, Yildiz S, La Marca A. Progestins for pituitary suppression during ovarian stimulation for ART: a comprehensive and systematic review including meta-analyses. Hum Reprod Update. 2021 Jan 4;27(1):48-66. doi: 10.1093/humupd/dmaa040.
- Background: PubMed 31371053Yildiz S, Turkgeldi E, Angun B, Eraslan A, Urman B, Ata B. Comparison of a novel flexible progestin primed ovarian stimulation protocol and the flexible gonadotropin-releasing hormone antagonist protocol for assisted reproductive technology. Fertil Steril. 2019 Oct;112(4):677-683. doi: 10.1016/j.fertnstert.2019.06.009. Epub 2019 Jul 29.
- Background: PubMed 32327297Alexandru P, Cekic SG, Yildiz S, Turkgeldi E, Ata B. Progestins versus GnRH analogues for pituitary suppression during ovarian stimulation for assisted reproductive technology: a systematic review and meta-analysis. Reprod Biomed Online. 2020 Jun;40(6):894-903. doi: 10.1016/j.rbmo.2020.01.027. Epub 2020 Feb 5.
- Background: PubMed 35989167Yang L, Luo K, Lu G, Lin G, Gong F. Euploidy rates among preimplantation genetic testing for aneuploidy cycles with oral dydrogesterone primed ovarian stimulation or GnRH antagonist protocol. Reprod Biomed Online. 2022 Oct;45(4):721-726. doi: 10.1016/j.rbmo.2022.03.003. Epub 2022 Mar 8.
- Background: PubMed 32395749La Marca A, Capuzzo M, Sacchi S, Imbrogno MG, Spinella F, Varricchio MT, Minasi MG, Greco P, Fiorentino F, Greco E. Comparison of euploidy rates of blastocysts in women treated with progestins or GnRH antagonist to prevent the luteinizing hormone surge during ovarian stimulation. Hum Reprod. 2020 Jun 1;35(6):1325-1331. doi: 10.1093/humrep/deaa068.
- Results publication: PubMed 30927417Begueria R, Garcia D, Vassena R, Rodriguez A. Medroxyprogesterone acetate versus ganirelix in oocyte donation: a randomized controlled trial. Hum Reprod. 2019 May 1;34(5):872-880. doi: 10.1093/humrep/dez034.
- Individual participant dataSharing planned: No
Related trials for Infertility
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
Active, not recruitingPhase 3
Human Menopausal Gonadotropin Research in Infertility Assessing Cumulative Live Birth With Frozen Embryo Transfer.
Infertility (IVF Patients)
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
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
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gonadotropin releasing hormone antagonist (Cetrotide), Medroxyprogesterone Acetate (Tarlusal) and Dydrogesterone in people with Infertility, run by Bezmialem Vakif University 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 3 inclusion and 7 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 15 Oct 2024. 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.
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?
Rate of clinical pregnancy (time frame: 4-5 weeks after IVF). 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 NCT05767086, which also lists 6 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 15 Oct 2024; AzTrials last refreshed its copy on 6 Nov 2026.