Comparison of 3 Different Protocols for Preventing Premature Ovulation in Ovarian Stimulation Cycles

October 9, 2024 updated by: Bezmialem Vakif University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

297

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Bezmialem Vakif University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 38 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Women aged 20-38 years who applied to the infertility clinic
  • BMI<25 kg/m2
  • AMH>1 ng/mL

Exclusion Criteria:

  • Adenomyosis
  • Endometriosis
  • Untreated uterine pathology
  • Hormonal therapy in the last 3 months
  • Contraindication for ovulation stimulation
  • BMI>25 kg/m2
  • AMH<1 ng/mL

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gonadotropin-releasing hormone (GnRH) antagonist
Cetrotide® (0.25 mg, MerckSerono Pharmaceuticals, Darmstadt, Germany)
Drug: Gonadotropin releasing hormone antagonist (Cetrotide)
clinical pregnancy rates
Other Names:
  • Cetrotide
Experimental: Medroxyprogesterone acetate
Tarlusal® (5 mg, Deva Pharma, Istanbul, Turkey)
Drug: Medroxyprogesterone Acetate (Tarlusal)
clinical pregnancy rates
Other Names:
  • Tarlusal
Experimental: Dydrogesterone
Duphaston® (10mg, Abbott Laboratories, Chicago, Illinois, ABD)
Drug: Dydrogesterone
clinical pregnancy rates
Other Names:
  • Duphaston (Duphaston)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of clinical pregnancy
Time Frame: 4-5 weeks after IVF
fetal heartbeat by transvaginal ultrasound
4-5 weeks after IVF

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of ongoing pregnancy
Time Frame: Months 3
Ongoing pregnancy rates 3 months after IVF
Months 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bezmialem Vakif University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2023

Primary Completion (Actual)

September 30, 2024

Study Completion (Actual)

September 30, 2024

Study Registration Dates

First Submitted

February 27, 2023

First Submitted That Met QC Criteria

March 13, 2023

First Posted (Actual)

March 14, 2023

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 9, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 30.01.2023-E.94828

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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