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Study of fixed-dose follitropin delta for ovarian stimulation in women undergoing intrauterine insemination treatment for infertility

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on treating infertility using follitropin delta, a hormone medication given by injection under the skin. The treatment is part of a process called intrauterine insemination (IUI), which is a fertility procedure where sperm is placed directly into the uterus to help achieve pregnancy. The study aims to observe how a fixed dose of follitropin delta affects the ovaries during stimulation for IUI treatment.

The treatment plan involves several medications. The main medication is Rekovelle (follitropin delta), which stimulates the ovaries to produce eggs. Other medications that may be used include Duphaston (dydrogesterone), Utrogestan (progesterone), and Ovitrelle (choriogonadotropin alfa). These medications work together to support the fertility treatment process.

During the study, participants may receive up to three treatment cycles. Each cycle involves daily injections of follitropin delta, followed by monitoring of the ovaries' response. The treatment period for each cycle lasts about two weeks, with breaks between cycles. The medications help prepare the body for the intrauterine insemination procedure by stimulating egg development and supporting the potential pregnancy.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment cycle begins

    The treatment starts with a fixed dose of follitropin delta (3.66 micrograms) given by subcutaneous injection

    Regular monitoring of follicle development through ultrasound examinations will occur

    Blood tests will measure hormone levels (E2, PG, LH)

  2. Step 2

    Ovulation triggering

    When follicles reach the appropriate size (14 mm or larger), choriogonadotropin alfa (Ovitrelle) will be administered by injection

    The endometrial thickness will be measured

  3. Step 3

    Intrauterine insemination procedure

    The intrauterine insemination (IUI) procedure will be performed

    Progesterone (Utrogestan 200 mg) will be administered vaginally for support after the procedure

    Dydrogesterone (Duphaston 10 mg) will be taken orally as prescribed

  4. Step 4

    Pregnancy testing and follow-up

    A pregnancy test will be performed to check for successful treatment

    If pregnancy is not achieved, up to three treatment cycles may be completed

    Each new cycle will start after a specific waiting period

  5. Step 5

    Monitoring throughout treatment

    Regular monitoring will continue for any side effects or complications

    The doctor will check for signs of ovarian hyperstimulation syndrome (OHSS)

    Treatment may be adjusted or cancelled if more than 2 follicles reach 14 mm or if 4 follicles reach 10 mm

Who can join the trial?

8 criteria

  • You must be a woman between 18 and 38 years old
  • You must have a normal ovulation cycle (regular monthly periods)
  • Your Body Mass Index (BMI) must be between 18 and 29 kg/m² (a measure of body weight relative to height)
  • You must have regular menstrual cycles occurring at predictable intervals
  • You must have at least one healthy Fallopian tube (the tube that connects ovary to uterus)
  • You must have a normal uterus cavity (the inner part of the womb must be healthy)
  • This must be your first time receiving IUI treatment (Intrauterine Insemination - a fertility procedure where sperm is placed directly into the uterus)
  • You must have social security coverage

Who cannot join the trial?

13 criteria

  • Age outside the range of 18-45 years
  • Male patients (study is only for female participants)
  • Body Mass Index (BMI) above 35 (BMI is a measure of body fat based on height and weight)
  • Current pregnancy or breastfeeding
  • Previous unsuccessful IUI treatments (IUI stands for Intrauterine Insemination, a fertility treatment)
  • Known allergies to follitropin delta (the study medication) or similar hormonal medications
  • History of ovarian cysts or Polycystic Ovary Syndrome (PCOS)
  • Abnormal thyroid function
  • Current use of other fertility medications
  • History of chemotherapy or radiation therapy affecting reproductive organs
  • Severe endometriosis (a condition where tissue similar to the uterus lining grows outside the uterus)
  • Major medical conditions that could interfere with fertility treatment
  • Participation in another clinical trial within the past 3 months
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Investigated drugs

Follitropin delta is a hormone medication used to stimulate the ovaries during fertility treatments. It helps the ovaries produce and develop eggs, which is an important part of intrauterine insemination (IUI) treatment. This synthetic hormone works similarly to the natural follicle-stimulating hormone (FSH) produced by the body. It helps women who are trying to conceive by promoting the growth and development of ovarian follicles that contain eggs.

What is already known about the treatment

Follitropin delta – A synthetic reproductive hormone administered through subcutaneous injection that belongs to the class of follicle-stimulating hormone (FSH) medications. This bioengineered hormone is specifically designed for controlled ovarian stimulation in women undergoing fertility treatments, particularly intrauterine insemination (IUI), by promoting the development and maturation of ovarian follicles. The medication works by binding to FSH receptors in the ovaries, stimulating the growth and development of eggs, with its molecular structure being specifically optimized for consistent and predictable ovarian response at a fixed dosage of 3.66 mcg.

Investigated diseases

Infertility - A condition characterized by the inability to achieve pregnancy after 12 months or more of regular unprotected sexual intercourse. In women, it can be caused by problems with ovulation, damage to the fallopian tubes, or issues with the uterus. The condition may also involve irregular menstrual cycles or hormonal imbalances that affect the release of eggs. Some cases involve problems with egg quality or quantity, while others may be related to structural issues in the reproductive system. Infertility can affect either partner or be a combination of factors from both partners.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-520681-22-00Protocol codeRISEEstimated enrolment80 patientsSponsorCentre Hospitalier Intercommunal Creteil

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