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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Intercommunal Creteil	Creteil	France

Other Sites

Site Name	City	Country
Cnazynq Dk Esynhb Dlxjsmyquluzrhfewik Jqoh Vzlwha	Bruges	France
Cyrbqmy Dn Gvbwcoltl Pbouioaypjpalbnsvzirgq dl Muxdmeah dh lx Refivurjjljk	Marseille	France
Czujuce Dy Nooettmp Mhtnnrfocsdazo Atcjtodna Ds Poulf	Neuilly-Sur-Seine	France
Cxmsscs Du Ngaolqb Cdmqeqvwtjypvyrr Aaj Shhvh Rxyg	Montpellier	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	02.06.2025

Trial locations

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.

Investigated diseases:

Infertility

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 ID:

2025-520681-22-00

Protocol code:

RISE

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?