NCT05767086

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
297

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 14, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

March 15, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

1.5 years

First QC Date

February 27, 2023

Last Update Submit

October 9, 2024

Conditions

Infertility

Keywords

ovulation inductionIVF

Outcome Measures

Primary Outcomes (1)

  • Rate of clinical pregnancy

    fetal heartbeat by transvaginal ultrasound

    4-5 weeks after IVF

Secondary Outcomes (1)

  • Rate of ongoing pregnancy

    Months 3

Study Arms (3)

Gonadotropin-releasing hormone (GnRH) antagonist

EXPERIMENTAL

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

Drug: Gonadotropin releasing hormone antagonist (Cetrotide)

Medroxyprogesterone acetate

EXPERIMENTAL

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

Drug: Medroxyprogesterone Acetate (Tarlusal)

Dydrogesterone

EXPERIMENTAL

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

Drug: Dydrogesterone

Interventions

Gonadotropin releasing hormone antagonist (Cetrotide)DRUG

clinical pregnancy rates

Also known as: Cetrotide
Gonadotropin-releasing hormone (GnRH) antagonist
Medroxyprogesterone Acetate (Tarlusal)DRUG

clinical pregnancy rates

Also known as: Tarlusal
Medroxyprogesterone acetate
DydrogesteroneDRUG

clinical pregnancy rates

Also known as: Duphaston (Duphaston)
Dydrogesterone

Eligibility Criteria

Age20 Years - 38 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

Location

Related Publications (6)

  • 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.

    PMID: 33016316BACKGROUND

  • 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.

    PMID: 31371053BACKGROUND

  • 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.

    PMID: 32327297BACKGROUND

  • 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.

    PMID: 35989167BACKGROUND

  • 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.

    PMID: 32395749BACKGROUND

  • 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.

    PMID: 30927417RESULT

MeSH Terms

Conditions

Infertility

Interventions

cetrorelixMedroxyprogesterone AcetateDydrogesterone

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

MedroxyprogesteroneHydroxyprogesteronesProgesteronePregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPregnadienes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2023

First Posted

March 14, 2023

Study Start

March 15, 2023

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)