Desogestrel Versus GnRH Antagonist in IVF/ICSI

NCT04728659 | Unknown Phase 4 DMC

• 1 other identifier: 01/2020
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

Progestin primed ovarian stimulation (PPOS) has been shown to be effective in avoiding premature spontaneous ovulation, without affecting the number of retrieved oocytes or the quality of the embryos obtained. The utilization of progestins permits lower costs, an easier administration (oral assumption instead of injections) and a tight control over LH levels. Hence the PPOS may be a valid alternative to the standard ovarian stimulation protocols. Additionally, it may be anticipated some degree of superiority of PPOS in particular categories of patients: donors, women at risk of OHSS, women who preserve their as well as poor responder or suboptimal responders for whom oocytes/embryo accumulation or double ovarian stimulation protocols are proposed The aim of this trial will be to investigate the use of Desogestrel in controlling the LH surge during ovarian stimulation in IVF/ICSI cycles. This study is a noninferiority trial in which the the primary efficacy endpoint will be the number of oocytes retrieved per patient. Sample size calculation was performed with the assumptions that the non-inferiority margin is corresponding to three or less oocytes . With the objective to demonstrate that the difference in average number of oocytes retrieved between the Desogestrel and the ganirelix groups would not exceed three, the power for a comparison between the two groups would be equal to 87% for 75 evaluable patients in each treatment groups (for an allocation of 1:1 and a total sample size of 150). To allocate at least 150 patients, an additional 10% to cover possible dropping out were planned to allocate. A total of 165 patients will be included in this study Patients will be assigned to either the study or the control group. The study group will be administered follitropin alfa (Bemfola 150-225 IU/die) and Desogestrel (Cerazette 75 mcg daily ) will be started on stimulation day 7 or when the leading follicle will reach 14 mm, whichever comes first. An antagonist protocol will be used for the control group. Patients will be administered follitropin alfa (Bemfola 150 - 225 IU/die) and Ganirelix (Orgalutran 0.25 mg/die) will be started on stimulation day 7 or when the leading follicle will reach 14 mm, whichever comes first. When a diameter of 18 mm is reached, the final stage of oocyte maturation will be triggered with triptorelin 0.2 mg + hCG 1000 U s.c. Fertilization of the aspirated oocytes will be carried out in vitro, by either conventional insemination or ICSI, depending on semen parameters. Viable embryos will be then frozen by means of vitrificaton on the day in which they will reach the blastocyst developmental stage.

Conditions

IVF; Infertility

Keywords

ovulation; progestin; PPOS; GnRH antagonist

Outcome Measures

Primary Outcomes (1)

• Number of retrieved oocyte

  The number of retrieved oocytes after ovarian stimulation

  14 days after ovarian stimulation

Secondary Outcomes (5)

• Number of patients with LH surge

  During the 14 days of ovarian stimulation

• cycle cancellation rate

  14 days after ovarian stimulation

• number of embryos

  7 days after oocyte reatrieval

• number of mature oocytes

  14 days after ovarian stimulation

• serum levels of progesterone

  14 days after ovarian stimulation

Study Arms (2)

Desogestrel Group

EXPERIMENTAL

Ovulation inhibition will be performed using Desogestrel (75 mcg) starting on stimulation day 7 or when the leading follicle will reach 14 mm, whichever comes first

Drug: Desogestrel 0.075 MG

GnRH antagonist

ACTIVE COMPARATOR

Ovulation inhibition will be performed using ganirelix (Orgalutran, 0.25 mg/die) starting on stimulation day 7 or when the leading follicle will reach 14 mm, whichever comes first.

Drug: Orgalutran

Interventions

Desogestrel 0.075 MG DRUG

It will be given orally for 3 to 5 days during FSH administration for ovarian stimulation

Desogestrel Group

Orgalutran DRUG

It will be given subcutaneously for 3 to 5 days during FSH administration for ovarian stimulation

GnRH antagonist

Eligibility Criteria

• Age: 18 Years - 42 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• regular menstrual cycles over the previous 3-month period (25 - 35 days in duration)
• basal serum FSH concentration of no more than 10 IU/L

You may not qualify if:

• documented ovarian failure, including basal FSH above 10 IU/L or no antral follicles by ultrasound examination
• diagnosis of polycystic ovarian syndrome
• any controindication to ovarian stimulation treatment.

Sponsors & Collaborators

• Casa di Cura Privata Villa Mafalda: lead

Study Sites (1)

Villa Mafalda

Roma, Italy

RECRUITING

Related Publications (3)

• 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: 32395749 BACKGROUND

• 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: 33016316 BACKGROUND

• La Marca A, Capuzzo M. Use of progestins to inhibit spontaneous ovulation during ovarian stimulation: the beginning of a new era? Reprod Biomed Online. 2019 Aug;39(2):321-331. doi: 10.1016/j.rbmo.2019.03.212. Epub 2019 Mar 29.

  PMID: 31138494 BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

Desogestrel; ganirelix

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Ermanno Greco

CONTACT

+39335304960; ergreco1@virgilio.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: January 28, 2021
• Study Start: October 1, 2020
• Primary Completion: January 30, 2022
• Study Completion: February 28, 2022
• Last Updated: January 28, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)