Menopur And Rekovelle Combination Study

Study Overview
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Brief Summary
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This study proposes to evaluate the effect of adding HP-hMG (Menopur) to follitropin delta in a mixed protocol regimen, using an individualized, fixed dose of follitropin delta based on the established algorithm, combined with a variable, adjustable dose of Menopur based on body weight and ovarian reserve.

Detailed Description
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The initial dose of follitropin delta will be determined at enrolment by the analysis of serum AMH on days 2 to 5 of the menstrual cycle preceding the IVF treatment cycle and body weight in Kg The initial dose of HP-hMG to be added on top of follitropin delta will be determined at enrolment by the total follitropin delta dose and body weight in Kg

Official Title
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An Exploratory Study to Evaluate a Mixed Protocol of Menopur (Highly Purified Human Menopausal Gonadotropin) and REKOVELLE (Follitropin Delta) for Controlled Ovarian Stimulation in IVF (in Vitro Fertilization)

Conditions
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Fertility Disorders

Intervention / Treatment
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* Combination Product: Follitropin delta and HP-hMG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women 18 to 40 years of age undergoing their first IVF/ICSI cycle Diagnosed with unexplained infertility, tubal infertility, endometriosis stage I/II, or with partners diagnosed with male factor infertility Regular menstrual cycles of 24-35 days Presence of both ovaries Early follicular phase FSH serum concentration <10 IU/L measured between Day 2 to Day 5 of menstrual cycle within the previous 12 months Ejaculated sperm (fresh or frozen) for insemination Exclusion Criteria: Inability to consent Endometriosis stage III and IV High risk of OHSS (AMH ≥ 35 pmol/L) History of recurrent miscarriages defined as ≥ 3 consecutive losses Women undergoing egg donation Women participating in any other research project Use of hormonal preparations (except for thyroid medication) during the last menstrual cycle Hypersensitivity to follitropin delta and/or HP-hMG

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Follitropin delta and HP-hMG<br>Follitropin delta combined with highly purified human menopausal gonadotrophin | Combination Product: Follitropin delta and HP-hMG<br>* Follitropin delta dose will be determined by AMG and weight in Kg. Highly purified human menopausal gonadotrophin will be determined by follitropin delta dose and body weight in Kg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the number of utilizable blastocysts on Day 5 or Day 6 of embryo culture | Utilizable blastocyst is defined as embryo at day 5 or 6 suitable for transfer | 6 days of embryo culture | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine dosage of REKOVELLE and Menopur in a mixed protocol | Evaluate the effect of adding HP-hMG (Menopur) to follitropin delta (REKOVELLE) during IVF stimulation | up to 20 days | 
| Evaluate the safety profile of the REKOVELLE - Menopur mixed protocol algorithm | The safety profile is the proportion of women with early and late OHSS and/or preventive interventions for early OHSS (i.e., triggering with GnRH agonist, use of dopamine agonist, conversion of planned fresh transfer into a freeze-all). OHSS is defined as an iatrogenic complication that occurs mainly due to ovarian overstimulation by gonadotropins. | up to 20 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovarian Response, In vitro fertilization, Controlled ovarian stimulation