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

Primary Purpose

Infertility

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Gonadotropin releasing hormone antagonist (Cetrotide)
Medroxyprogesterone Acetate (Tarlusal)
Dydrogesterone
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infertility focused on measuring ovulation induction, IVF

Eligibility Criteria

20 Years - 38 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Bezmialem Vakif UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Gonadotropin-releasing hormone (GnRH) antagonist

Medroxyprogesterone acetate

Dydrogesterone

Arm Description

Cetrotide® (0.25 mg, MerckSerono Pharmaceuticals, Darmstadt, Germany)

Tarlusal® (5 mg, Deva Pharma, Istanbul, Turkey)

Duphaston® (10mg, Abbott Laboratories, Chicago, Illinois, ABD)

Outcomes

Primary Outcome Measures

Rate of clinical pregnancy
fetal heartbeat by transvaginal ultrasound

Secondary Outcome Measures

Rate of ongoing pregnancy
Ongoing pregnancy rates 3 months after IVF

Full Information

First Posted
February 27, 2023
Last Updated
October 10, 2023
Sponsor
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT05767086
Brief Title
Comparison of 3 Different Protocols for Preventing Premature Ovulation in Ovarian Stimulation Cycles
Official Title
Comparison of Cetrorelix, Medroxyprogesterone Acetate and Dydrogesterone for Preventing Premature Ovulation in Ovarian Stimulation Cycles
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2023 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
ovulation induction, IVF

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
297 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gonadotropin-releasing hormone (GnRH) antagonist
Arm Type
Experimental
Arm Description
Cetrotide® (0.25 mg, MerckSerono Pharmaceuticals, Darmstadt, Germany)
Arm Title
Medroxyprogesterone acetate
Arm Type
Experimental
Arm Description
Tarlusal® (5 mg, Deva Pharma, Istanbul, Turkey)
Arm Title
Dydrogesterone
Arm Type
Experimental
Arm Description
Duphaston® (10mg, Abbott Laboratories, Chicago, Illinois, ABD)
Intervention Type
Drug
Intervention Name(s)
Gonadotropin releasing hormone antagonist (Cetrotide)
Other Intervention Name(s)
Cetrotide
Intervention Description
clinical pregnancy rates
Intervention Type
Drug
Intervention Name(s)
Medroxyprogesterone Acetate (Tarlusal)
Other Intervention Name(s)
Tarlusal
Intervention Description
clinical pregnancy rates
Intervention Type
Drug
Intervention Name(s)
Dydrogesterone
Other Intervention Name(s)
Duphaston (Duphaston)
Intervention Description
clinical pregnancy rates
Primary Outcome Measure Information:
Title
Rate of clinical pregnancy
Description
fetal heartbeat by transvaginal ultrasound
Time Frame
4-5 weeks after IVF
Secondary Outcome Measure Information:
Title
Rate of ongoing pregnancy
Description
Ongoing pregnancy rates 3 months after IVF
Time Frame
Months 3

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pinar Ozcan, MD,PhD
Phone
+902124531700
Email
drpinarozcan@hotmail.com
Facility Information:
Facility Name
Bezmialem Vakif University
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pinar Ozcan, MD, PhD
Phone
+902124531700
Email
drpinarozcan@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33016316
Citation
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.
Results Reference
background
PubMed Identifier
31371053
Citation
Yildiz 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.
Results Reference
background
PubMed Identifier
32327297
Citation
Alexandru 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.
Results Reference
background
PubMed Identifier
35989167
Citation
Yang 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.
Results Reference
background
PubMed Identifier
32395749
Citation
La 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 Reference
background
PubMed Identifier
30927417
Citation
Begueria 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.
Results Reference
result

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

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