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Ovulation induction and luteal phase support with GnRH agonists in in vitro fertilization
EU CTIS ID: 2023-505126-34-00
What this study is testing
Demonstrate an increase in the rate of live births after 22 weeks' amenorrhea (SA) per cycle with GnRH agonist induction and support compared with the reference protocol combining hCG induction and luteal support with exogenous vaginal progesterone.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients requiring conventional IVF or IVF with sperm injection (ICSI) from a partner or donor under the conditions defined by French law, after agreement by a multidisciplinary consultation meeting
- Signed informed consent
- Social security affiliation (excluding AME)
- Patients aged 18 to 39 included
- First, second or third attempt at IVF or ICSI for a pregnancy
- BMI < 35 kg/m2
You likely can't join if
- Patient with HIV
- Known hypersensitivity to the investigational drugs and/or their excipients (human chorionic gonadotropin, progesterone, nafarelin acetate, GnRH, GnRH analogues, mannitol, sodium chloride, water for injection, glacial acetic acid, sodium hydroxide and/or hydrochloric acid, sorbitol, purified water, benzalkonium chloride, sunflower oil, soy lecithin, gelatin, glycerol, titanium dioxide (E171), methionine, poloxamer 18, phosphoric acid)
- Gynaecological bleeding or genital haemorrhage
- Tumors of the hypothalamus or pituitary gland
- Impaired renal function
- Major characterized depressive episode in progress
See the full eligibility criteria
- Patients requiring conventional IVF or IVF with sperm injection (ICSI) from a partner or donor under the conditions defined by French law, after agreement by a multidisciplinary consultation meeting
- Signed informed consent
- Social security affiliation (excluding AME)
- Patients aged 18 to 39 included
- First, second or third attempt at IVF or ICSI for a pregnancy
- BMI < 35 kg/m2
- AMH > 1 ng/ml (= 7 pmol/L) and/or antral follicle count ≥ 8 in the assessment in the year before inclusion
- AMH <5 ng/ml and/or antral follicle count <40 in the year before inclusion
- Antagonist protocol (programmed or not)
- Treatment with daily recombinant FSH
- Initial dose of daily recombinant FSH between 75 and 450 IU or 5 à 30 µg
- Patient with HIV
- Known hypersensitivity to the investigational drugs and/or their excipients (human chorionic gonadotropin, progesterone, nafarelin acetate, GnRH, GnRH analogues, mannitol, sodium chloride, water for injection, glacial acetic acid, sodium hydroxide and/or hydrochloric acid, sorbitol, purified water, benzalkonium chloride, sunflower oil, soy lecithin, gelatin, glycerol, titanium dioxide (E171), methionine, poloxamer 18, phosphoric acid)
- Gynaecological bleeding or genital haemorrhage
- Tumors of the hypothalamus or pituitary gland
- Impaired renal function
- Major characterized depressive episode in progress
- Ovarian hypertrophy or cysts unrelated to polycystic ovary syndrome
- Severe adenomyosis requiring a long protocol
- Carcinoma of the ovary, uterus or breast
- Progressive thromboembolic events
- Severe impairment of liver function
- Current participation in another therapeutic interventional trial on the day of inclusion
- Breast-feeding women
- Patients under safeguard of justice, guardianship or curatorship
- History of epilepsy and/or intracranial tumors potentially causing epilepsy
- Patients who do not speak or understand French
- ICSI with sperm from testicular biopsy
- Pre-implantation diagnosis
- Hypogonadotropic hypogonadism (amenorrhea or spaniomenorrhea with basal LH <1.2 IU/L)
- History of severe ovarian hyperstimulation syndrome (OHSS)
- Unoperated hydrosalpinx
- Intracavitary polyps or myomas deforming the cavity
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.