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Study of Semaglutide on Embryo Quality in Overweight and Obese Women Undergoing In Vitro Fertilization for Infertility

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What is this trial about?

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

This study looks at infertility in women who are overweight or obese and are planning to undergo In Vitro Fertilization, which is a procedure where eggs are collected from the ovaries and fertilized with sperm in a laboratory to create embryos. The study will use Wegovy, which contains semaglutide, a medication that is given as an injection under the skin. Some women will receive semaglutide for 12 weeks before starting their fertility treatment, while others will not receive this pre-treatment. During the fertility procedure itself, all women will receive standard medications including ganirelix, which helps control the timing of egg release, follitropin alfa, which stimulates the ovaries to produce eggs, and triptorelin, which also helps regulate hormones during the treatment.

The purpose of this study is to find out whether treatment with semaglutide for 12 weeks before starting fertility treatment can improve the number of good quality embryos that develop to the blastocyst stage, which is an important stage of early embryo development that occurs about five to six days after fertilization. The study will compare results between women who receive semaglutide before their fertility treatment and those who do not receive this pre-treatment.

Women in the group receiving semaglutide will take this medication for 12 weeks before beginning their fertility treatment. After this period, all women will undergo the standard fertility treatment process where their ovaries are stimulated with medications to produce multiple eggs, the eggs are collected, fertilized in the laboratory, and the resulting embryos are observed as they develop and then frozen for future use. The study will track various aspects of embryo development using time-lapse monitoring, which allows continuous observation of how embryos grow and divide. The study will also measure changes in body weight, body mass index, and markers of ovarian function before and after the semaglutide treatment period.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Group assignment

    Upon joining the study, you will be randomly assigned to one of two groups.

    Group A will receive treatment with semaglutide for 12 weeks before starting the fertility procedure.

    Group B will not receive any pre-treatment and will proceed directly to the fertility procedure.

  2. Step 2

    Pre-treatment phase for Group A

    If you are assigned to Group A, you will receive semaglutide (brand name Wegovy) for a period of 12 weeks.

    The medication is administered as a 1 mg injection under the skin using a pre-filled pen.

    During this 12-week period, your body weight, body mass index, and waist circumference will be measured before and after the treatment.

    Your ovarian reserve markers will also be assessed before and after the treatment. These markers include the antral follicle count (the number of small follicles in the ovaries visible on ultrasound) and antimullerian hormone (a blood test that indicates egg supply).

  3. Step 3

    No pre-treatment phase for Group B

    If you are assigned to Group B, you will not receive the 12-week pre-treatment with semaglutide.

    You will proceed directly to the fertility treatment phase.

  4. Step 4

    Ovarian stimulation phase

    Both groups will undergo ovarian stimulation as part of the in vitro fertilization procedure.

    You will receive follitropin alfa (brand name Bemfola), which is a medication that stimulates the ovaries to produce multiple eggs. The dose is 300 IU per 0.50 mL, administered as an injection under the skin using a pre-filled pen.

    The number of days of stimulation and the total dose of gonadotropins (hormones that stimulate the ovaries) will be recorded.

    You will also receive ganirelix (brand name Ganirelix Gedeon Richter) at a dose of 0.25 mg per 0.5 mL, administered as an injection under the skin using a pre-filled syringe. This medication prevents premature ovulation.

    Alternatively, you may receive triptorelin (brand name Decapeptyl diario) at a dose of 0.1 mg, administered as an injection under the skin after mixing the powder with the provided solvent.

  5. Step 5

    Egg collection

    After the ovarian stimulation, your eggs will be collected during a medical procedure.

    The number of cumulus-oocyte complexes (eggs surrounded by supporting cells) will be counted.

    The number of mature eggs (referred to as MII eggs) will also be recorded.

  6. Step 6

    Fertilization

    The collected eggs will be fertilized in the laboratory.

    The fertilization rate (the proportion of eggs that are successfully fertilized) will be calculated.

    The timing of specific fertilization events will be monitored, including when the second polar body appears (a sign of egg maturation), when the pronuclei (structures containing genetic material from both egg and sperm) appear and disappear.

  7. Step 7

    Embryo development monitoring

    The fertilized eggs will develop into embryos, and their growth will be closely monitored.

    The timing of cell divisions will be recorded, including when the embryo divides into 2, 3, 4, 5, 6, 7, and 8 cells.

    Further developmental stages will be tracked, including compaction (when cells stick together), morula stage (a ball of cells), cavitation (when a fluid-filled space forms), and full blastocyst formation (a more advanced embryo stage).

    The total number of embryos that reach the blastocyst stage on day 5 will be counted.

    The blastocyst formation rate, which is the proportion of fertilized eggs that develop into blastocysts, will be calculated.

    The number of good quality blastocysts will be determined. This is the main focus of the study.

  8. Step 8

    Embryo freezing

    All embryos will be frozen as part of a freeze-all strategy.

    The number of embryos that are cryopreserved (frozen for future use) will be recorded.

    The stage of each embryo at the time of freezing will be noted, including whether it was frozen on day 5, day 6, or day 7 of development.

Who can join the trial?

6 criteria

  • You must be 38 years old or younger
  • Your AMH level (a blood test that measures your egg supply, also called Anti-Müllerian Hormone) must be 1 ng/mL or higher
  • Your AFC (the number of small fluid-filled sacs in your ovaries counted by ultrasound, also called Antral Follicle Count) must be 6 or more
  • Your body mass index (a measure of body weight relative to height, also called BMI) must be between 27 kg/m² and 40 kg/m², which means you are overweight or obese
  • You must be planning to have IVF treatment (a fertility procedure where eggs are fertilized outside the body, also called In Vitro Fertilization) with a freeze-all strategy (all embryos created will be frozen for later use rather than transferred immediately)
  • You must be female

Who cannot join the trial?

5 criteria

  • The source data does not provide specific exclusion criteria for this clinical trial
  • This study is only for female patients, so male patients cannot participate
  • This study is for adults only, so children and teenagers under 18 years old cannot participate
  • This study is for patients with infertility, which means difficulty getting pregnant naturally, so patients without fertility issues cannot participate
  • This study is specifically for overweight and obese patients undergoing IVF cycles (a medical procedure where eggs are fertilized outside the body to help with pregnancy), so patients with normal weight may not be eligible
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Investigated drugs

Semaglutide is a medication that helps control blood sugar levels and is also used for weight management. In this trial, it is being tested to see if taking it for 12 weeks before fertility treatment might improve the quality of embryos in women who are overweight or obese and undergoing in vitro fertilization.

What is already known about the treatment

Semaglutide – Semaglutide is a medication given as a once-weekly injection under the skin that helps control blood sugar levels and reduce body weight. It is currently approved for treating type 2 diabetes and obesity, and is being studied in clinical trials to see if it might improve fertility outcomes in overweight and obese women undergoing in vitro fertilization. The drug works by mimicking a natural hormone called GLP-1 that helps regulate appetite, slows down digestion, and improves how the body processes sugar. It belongs to a class of medications called GLP-1 receptor agonists, which activate specific receptors in the body to produce these beneficial effects.

Investigated diseases

Infertility – Infertility is a condition of the reproductive system where a person or couple is unable to achieve pregnancy after one year or more of regular unprotected sexual intercourse. This condition can affect both men and women and may result from various factors including hormonal imbalances, structural problems in the reproductive organs, or issues with egg or sperm production. In women, infertility can be associated with ovulation disorders, blocked fallopian tubes, endometriosis, or age-related decline in egg quality. In men, it may involve low sperm count, poor sperm movement, or abnormal sperm shape. The condition can be primary, meaning the person has never achieved pregnancy, or secondary, meaning pregnancy has occurred before but cannot be achieved again. Infertility may be temporary or permanent depending on the underlying causes.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522525-34-00Estimated enrolment62 patientsSponsorSantiago Dexeus Font Fundacio Privada

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