NCT03895099

Brief Summary

Oocyte donation is a cumbersome and demanding procedure, involving an injectable hormonal treatment for an average duration of 12 days, according to the protocols, 1 to several daily injections. The objective of this study is to show that treatments can be simplified without reducing the number of oocytes that have been punctured, by blocking the luteinizing hormone (LH) surge by using oral progesterone and by limiting the number of injections of gonadotropins using corifollitropin alpha, regardless of the start date of the pacing protocol during a natural cycle.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2020

Typical duration for phase_3

Geographic Reach
1 country

4 active sites

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

March 28, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 29, 2019

Completed
1.4 years until next milestone

Study Start

First participant enrolled

September 4, 2020

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

3.2 years

First QC Date

March 28, 2019

Last Update Submit

November 3, 2023

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Number of oocytes punctured

    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.

    45 days

Secondary Outcomes (5)

  • Premature peak of LH

    45 days

  • Hyperstimulation syndrome

    45 days

  • Number of injection

    45 days

  • Number of Recombinant follicle stimulating hormone (r-FSH) units required for ovarian stimulation

    45 days

  • Number of days of stimulation

    45 days

Study Arms (5)

A - Early follicular phase

EXPERIMENTAL

Treatment by desogestrel at day 1 to day 3

Drug: Desogestrel early follicular phase

B - Medium follicular phase

EXPERIMENTAL

Treatment by desogestrel at day 4 to day 7

Drug: Desogestrel medium follicular phase

C - Late follicular phase

EXPERIMENTAL

Treatment by desogestrel at day 7 to day 11

Drug: Desogestrel ovulatory phase

D - Ovulatory Phase

EXPERIMENTAL

Treatment by desogestrel at day 12 to day 15

Drug: Desogestrel late follicular phase

E - Luteal phase

EXPERIMENTAL

Treatment by desogestrel at day 16 to day 30

Drug: Desogestrel luteal phase

Interventions

Desogestrel early follicular phaseDRUG

Start of ovarian stimulation in early follicular phase

A - Early follicular phase
Desogestrel medium follicular phaseDRUG

Start of ovarian stimulation in medium follicular phase

B - Medium follicular phase
Desogestrel ovulatory phaseDRUG

Start of ovarian stimulation in ate follicular phase

C - Late follicular phase
Desogestrel late follicular phaseDRUG

Start of ovarian stimulation in ovulatory Phase

D - Ovulatory Phase
Desogestrel luteal phaseDRUG

Start of ovarian stimulation in luteal phase

E - Luteal phase

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Stage 3-4 endometriosis
  • ovarian cyst\> 30 mm,
  • Polycystic ovary syndrome
  • Patient under tutorship or curatorship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CHRU Lille

Lille, France

Location

CHU Bondy

Paris, France

Location

CHU Tenon

Paris, France

Location

Clinique de la Sagesse

Rennes, 35043, France

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2019

First Posted

March 29, 2019

Study Start

September 4, 2020

Primary Completion

October 30, 2023

Study Completion

October 30, 2023

Last Updated

November 7, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(4)