Ovarian stimulation protocol with ultra flexible and ultra simplified start for oocyte donors

Feasibility and efficacy of a new ovarian stimulation regimen with RANDom start, use of corifollitropin alpha and progestin protocol for Oocyte donorS - RANDOS

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003106-29-FR

Enrollment

110

Registered

2018-09-25

Start date

2019-01-17

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

infertility MedDRA version: 20.0 Level: PT Classification code 10021926 Term: Infertility System Organ Class: 10038604 - Reproductive system and breast disorders

Interventions

Trade Name: DESOGESTREL Product Name: DESOGESTREL Pharmaceutical Form: Coated tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Donor of oocytes having spontaneous and regular menstrual cycles, and having taken no hormonal treatment (in particular contraceptive) during the cycle preceding the donation. - Patient with normal ovarian reserve with antral follicle count> 8, - BMI between 18 and 32 - Regular natural menstrual cycles, and absence of hormonal treatment during the cycle preceding the donation cycle - Major patient - Affiliation to social security Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 110 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Stage 3-4 endometriosis - ovarian cyst> 30 mm, - Polycystic ovary syndrome - Patient under tutorship or curatorship

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of the study is to compare the number of oocytes punctured after a progestogen-induced ovarian stimulation protocol, random start, depending on the phase of the cycle on the day of the beginning of ovarian stimulation.;Secondary Objective: - Show the effectiveness of LH peak blockade by oral progesterone administration - To show the effectiveness of LH peak blockade by the administration of oral progesterone irrespective of the phase of the menstrual cycle on the day of stimulation initiation - To describe the evolution of the hormonal parameters of the patients under treatment by Desogestrel (LH, progesterone, Estradiolemia) - To evaluate the differences of the stimulation parameters (duration, doses, number of injections ..) according to the groups of randomization [in connection with the main objective];Primary end point(s): The primary endpoint is the number of oocytes punctured after ovarian stimulation as described above, regardless of the phase of the menstrual cycle at the time of injection of corifollitropin alpha.;Timepoint(s) of evaluation of this end point: At the day of oocytes retrieval	—

Measure

Time frame

Main Objective: The main objective of the study is to compare the number of oocytes punctured after a progestogen-induced ovarian stimulation protocol, random start, depending on the phase of the cycle on the day of the beginning of ovarian stimulation.;Secondary Objective: - Show the effectiveness of LH peak blockade by oral progesterone administration - To show the effectiveness of LH peak blockade by the administration of oral progesterone irrespective of the phase of the menstrual cycle on the day of stimulation initiation - To describe the evolution of the hormonal parameters of the patients under treatment by Desogestrel (LH, progesterone, Estradiolemia) - To evaluate the differences of the stimulation parameters (duration, doses, number of injections ..) according to the groups of randomization [in connection with the main objective];Primary end point(s): The primary endpoint is the number of oocytes punctured after ovarian stimulation as described above, regardless of the phase of the menstrual cycle at the time of injection of corifollitropin alpha.;Timepoint(s) of evaluation of this end point: At the day of oocytes retrieval

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Secondary

Measure	Time frame
Secondary end point(s): - the number of mature oocytes, - The occurrence of a premature LH surge, and its frequency - The occurrence of moderate or severe ovarian hyperstimulation syndrome - The number of injections needed, - The number of r-FSH units required for ovarian stimulation, - The number of days of stimulation.;Timepoint(s) of evaluation of this end point: At the day of oocytes retrieval	—

Measure

Time frame

Secondary end point(s): - the number of mature oocytes, - The occurrence of a premature LH surge, and its frequency - The occurrence of moderate or severe ovarian hyperstimulation syndrome - The number of injections needed, - The number of r-FSH units required for ovarian stimulation, - The number of days of stimulation.;Timepoint(s) of evaluation of this end point: At the day of oocytes retrieval

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Countries

France

Contacts

Public ContactClinical Research Center

CHI Créteil

m.brussieux.chic@gmail.com15702261233

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026