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New treatment option for Infertility
Official title Using a Fixed Dosage of Follitropin Delta for Ovarian Stimulation for Intrauterine Insemination: Rekovelle for Intrauterine Successful Experience (RISE)
ClinicalTrials.gov ID: NCT07153367
What this study is testing
What is REKOVELLE (Follitropin Delta)?
REKOVELLE (Follitropin Delta) is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for infertility.
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 aim of this study is to evaluate the use of a fixed dose of 3.66 mcg of follitropin delta (Rekovelle) on ovarian response during ovarian stimulation for intrauterine insemination (IUI). The assumption is that this fixed dose will be effective while minimizing the risk of multiple pregnancies.
- Phase 2: a mid-size study of how well it works
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 38, women only
You may be able to join if
- Normo-ovulatory patients
- 18 - 38 included years old
- BMI between 18 and 29 included kg/m²
- Regular menstrual cycles
- At least one healthy Fallopian tube
You likely can't join if
- Endometriosis Stage III
- Total mobile sperm count \<1 million
- Severe spermatogenesis disorders
- Women with Poly Cystic Ovary Syndrom
- History of OHSS or excessive response to gonadotrophins
- Chronic disease with contraindication to ovarian stimulation with gonadotrophins
See the full eligibility criteria
- Normo-ovulatory patients
- 18 - 38 included years old
- BMI between 18 and 29 included kg/m²
- Regular menstrual cycles
- At least one healthy Fallopian tube
- Normal uterus cavity
- First treatment for IUI
- Affiliation to the social security
- Endometriosis Stage III
- Total mobile sperm count \<1 million
- Severe spermatogenesis disorders
- Women with Poly Cystic Ovary Syndrom
- History of OHSS or excessive response to gonadotrophins
- Chronic disease with contraindication to ovarian stimulation with gonadotrophins
- Known genetic disease
- Hypothalamus or pituitary tumors
- Ovarian hypertrophy or ovarian cyst not due to polycystic ovary syndrome
- Gynecological bleeding of unknown etiology
- Ovarian, uterine or breast carcinoma
- Primary ovarian failure
- Genital malformations incompatible with pregnancy
- Uterine fibroids incompatible with pregnancy
- Protected persons (pregnant women, nursing mothers, person under guardianship, minors, persons deprived of liberty, and persons unable to give consent)
- Tumors (including meningioma) whose development is known or suspected to be progesterone-dependent
- History of hepatic dysfunction
- Have been receiving progestogen therapy for more than 6 months
- Known contraindication to hormonal treatments (progestogens or oestrogens), or with a history of adverse events related to their use
- Previous thromboembolism events during or following the use of gonadotrophins or with high risk factors for thromboembolic events (venous or arterial)
- Previous or current treatment with gonadotrophins
- Hypersensitivity to the active substance or to any of the excipients
- High risk of OHSS such as women with AMH ≥ 35 pmol/L
- History of severe uterine malformation (unicornuate or bicornuate uterus),
- Past history of ovarian torsion
- Uncontrolled thyroid dysfunction
- Uncontrolled adrenal dysfunction
- Hydrosalpynx
- Breast pathologies not compatible with gonadotrophin stimulation
- Use of infertility medications that could affect follicle stimulation and maturation such as GH
- Participation in other treatment research
- Not able to understand and sign the written informed consent form
The study team makes the final eligibility decision.
Where it's taking place
- Bruges, France
- Créteil, France
- Marseille, France
- Montpellier, France
- Neuilly-sur-Seine, 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 38 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bruges, France; Créteil, France; Marseille, France; Montpellier, France; Neuilly-sur-Seine, 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.