Ovarian Stimulation With FSH Alone Versus FSH Plus GnRH Antagonist in an Oocyte Donor/Recipient Programme

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-07-01

Brief Summary

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The aim of this study is to compare the efficacy of a protocol using FSH alone with that of a protocol using FSH plus a GnRH antagonist for controlled ovarian hyperstimulation in cycles of elective freezing in the context of a donor/recipient programme.

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Detailed Description

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The hypothesis to be tested is that an ovarian stimulation protocol that includes FSH alone without any LH surge prevention regimens is not inferior to a protocol including FSH plus a GnRH antagonist in terms of clinical outcome in a donor/recipient model.

The formal sample size is calculated as follows:

If there is a true difference in favour of the experimental treatment of 5% (20% vs 15%), then 160 patients (80 per group in case of 1:1 enrolment) are required to be 80% sure that the upper limit of a one-sided 95% confidence interval (or equivalently a 90% two-sided confidence interval) will exclude a difference in favour of the standard/control group of more than 10%.

In the context of the present pilot study (as a first stage), the investigators intend to study 50 patients (25 per group in case of 1:1 enrolment). At a second stage the above mentioned sample size will be used.

Conditions

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Premature Luteinisation Progesterone Elevation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Protocol using FSH alone with that of a protocol using FSH plus a GnRH antagonist for controlled ovarian hyperstimulation in cycles of elective freezing in the context of a donor/recipient programme.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FSH only (no GnRH antagonist)

Women receive only FSH starting on day 2 of the cycle. The starting dose of FSH is 225-300 IU s.c. for the first 4 days adjusted thereafter according to the ovarian response.

Group Type EXPERIMENTAL

GnRH antagonist

Intervention Type OTHER

The GnRH antagonist in the control group (standard therapy) is administered from day 6 of FSH treatment at the dose of 0.25 mg per day until the triggering day and is injected each time immediately after the injection of FSH.

FSH + GnRH antagonist

Women receive 225-300 IU s.c. FSH, and a GnRH antagonist from day 6 of FSH treatment at the dose of 0.25 mg per day until the triggering day. The GnRH antagonist in group 2 is injected each time immediately after the injection of FSH.

Group Type ACTIVE_COMPARATOR

GnRH antagonist

Intervention Type OTHER

The GnRH antagonist in the control group (standard therapy) is administered from day 6 of FSH treatment at the dose of 0.25 mg per day until the triggering day and is injected each time immediately after the injection of FSH.

Interventions

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GnRH antagonist

The GnRH antagonist in the control group (standard therapy) is administered from day 6 of FSH treatment at the dose of 0.25 mg per day until the triggering day and is injected each time immediately after the injection of FSH.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* healthy women 21-32 years old with a BMI of 21 to 29 kg/m2 who wish to donate their oocytes
* normal ovarian reserve tests
* normal menstrual cycles of 26-32 days
* the women would not have received any hormonal treatment during the last three months before entering the study.

* absence of coagulation and/or autoimmune disorders.

Exclusion Criteria

1. Use of other protocols towards oocyte retrieval, such as natural, or modified natural cycles
2. Poor ovarian response according to the Bologna criteria \[22\],
3. History of endocrine or metabolic disorders, ovarian cystectomy or oophorectomy,
4. Women with the diagnosis of polycystic ovary syndrome
5. Clinical and/or laboratory markers of hereditary or acquired thrombophilia that complied to the standard protocols of each Unit.

* Non-hormonal medication for a serious medical condition

Minimum Eligible Age

21 Years

Maximum Eligible Age

32 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes