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New treatment option for In Vitro Fertilization
Official title Luteal Phase Support With GnRH Agonist After GnRH Agonist Triggering in IVF/ICSI Cycles
ClinicalTrials.gov ID: NCT06150703
What this study is testing
What is Ovulation induction with hCG + Luteal phase support with vaginal progesterone?
Ovulation induction with hCG + Luteal phase support with vaginal progesterone is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for in vitro fertilization.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The development of stimulation protocols for in vitro fertilisation (IVF) has led to a paradox. It has now been established that obtaining a large number of oocytes is a key to success, but that it is also a risk factor for embryo transfer failure after puncture (disruption of endometrial receptivity due to luteal insufficiency) and a risk factor for complications such as ovarian hyperstimulation syndrome (OHSS).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 39, women only
You may be able to join if
- Patients requiring conventional IVF or IVF with sperm injection (ICSI) from the partner or donor under the conditions of management defined by French...
- Patients aged 18 to 39 included
- First or second attempt at IVF or ICSI for pregnancy
- BMI \< 35 kg/m2
- Anti-Mullerian hormone (AMH) \> 1 ng/ml (= 7 pmol/L) and/or antral follicle count ≥ 8 within the year prior to inclusion
You likely can't join if
- Patient diagnosed with HIV infection
- 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
See the full eligibility criteria
- Patients requiring conventional IVF or IVF with sperm injection (ICSI) from the partner or donor under the conditions of management defined by French law.
- Patients aged 18 to 39 included
- First or second attempt at IVF or ICSI for pregnancy
- BMI \< 35 kg/m2
- Anti-Mullerian hormone (AMH) \> 1 ng/ml (= 7 pmol/L) and/or antral follicle count ≥ 8 within the year prior to inclusion
- AMH \< 5 ng/ml and/or antral follicle count \<40 within the year prior to inclusion
- Treatment with recombinant FSH
- Antagonist protocol (with pre-treatment or not)
- Initial dose of recombinant FSH between 75 and 450 IU
- Signed informed consent
- Affiliation to the social security system (excluding AME)
- Patient diagnosed with HIV infection
- 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
- 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...
- Gynaecological bleeding or genital haemorrhage
- History of epilepsy and/or intracranial tumors potentially causing epilepsy
- Tumours of the hypothalamus or pituitary gland
- Ovarian enlargement or cysts unrelated to polycystic ovary syndrome
- Severe adenomyosis requiring a long protocol
- Carcinoma of the ovary, uterus or breast
- Active thromboembolic events
- Severe impairment of liver function
- Breastfeeding women
- Patients under court protection, guardianship or curators
- Current participation in another therapeutic treatment trial on the day of inclusion
- Patients who do not speak or understand French
The study team makes the final eligibility decision.
Where it's taking place
- Bondy, France
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 years to 39 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bondy, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.