RecruitingPHASE2, PHASE3INTERVENTIONAL

Benefit of GnRH Agonist Before Frozen Embryo Transfer in Patients With Endometriosis and/or Adenomyosis

This research is investigating whether a hormone treatment called a GnRH agonist can improve the chances of pregnancy for women with endometriosis or adenomyosis who are undergoing frozen embryo transfer. Endometriosis and adenomyosis are conditions that can make it harder to get pregnant. The study aims to find out if adding one or two injections of a GnRH agonist before the embryo transfer, in addition to the usual hormone support (oestrogens and progestins), helps the embryo to implant successfully. Doctors hope this additional step could increase the number of successful pregnancies for these patients. The study is comparing the effects of this extra injection against receiving only the standard hormone support.

At a glance

Status

Recruiting

Phase

PHASE2, PHASE3

Sponsor

Hopital Foch

Enrolment target

180

Start

18 Mar 2021

Estimated completion

18 Jun 2026

Endometriosis Adenomyosis Infertility, Female

What is this study about?

Many women who experience endometriosis or adenomyosis also find it difficult to get pregnant. Endometriosis is a condition where tissue similar to the lining of the womb grows outside it, causing pain and sometimes affecting fertility. Adenomyosis is when this womb lining tissue grows into the muscular wall of the womb itself. Both conditions can create an environment in the womb that makes it harder for an embryo to attach and grow.

Researchers believe that these conditions can cause increased inflammation in the womb, which might reduce the chances of a successful pregnancy. A type of medicine called a GnRH agonist is known to help reduce some of these inflammatory markers. This study is designed to see if giving a GnRH agonist injection before a frozen embryo transfer can create a more welcoming environment in the womb, thus improving the chances of a pregnancy.

During in vitro fertilisation (IVF), eggs are collected and fertilised in the lab. If there are extra embryos, they can be frozen for future use. A frozen embryo transfer is when one of these frozen embryos is thawed and placed back into the womb. This study will compare women who receive the standard hormone treatment (oestrogens and progestins) before their frozen embryo transfer with those who receive the standard treatment plus one or two doses of a GnRH agonist injection. The goal is to see if this extra injection can lead to more successful pregnancies.

Key takeaways

This study investigates a new approach to help women with endometriosis or adenomyosis get pregnant.
It tests if a hormone injection (GnRH agonist) improves success rates for frozen embryo transfers.
Participants will either receive standard care or standard care plus the injection.
The study aims to create a better environment in the womb for embryo implantation.
If successful, this could offer a new option for women facing fertility challenges with these conditions.

Who may be eligible?

This study is looking for women aged between 18 and 35 who have been diagnosed with endometriosis, adenomyosis, or both. You would have already gone through IVF treatment and have a frozen embryo (blastocyst) ready for transfer. Your womb should also appear normal on examinations.

You would not be able to join if you are under 18 or 36 and over, or if your body mass index (BMI) is over 35. You also cannot participate if you've had two or more failed embryo transfers in the past. Certain changes within the womb, like scars (synechiae), growths (polyps, fibroids, hyperplasia), or fluid build-up (hematometra), would also prevent you from joining. Similarly, if your MRI scan doesn't confirm endometriosis or adenomyosis, or if you have known blocked or swollen fallopian tubes, you wouldn't be eligible.

Finally, you cannot take part if you are allergic to any of the medicines used in the study, including the GnRH agonist (Decapeptyl 3mg), oestrogen, progesterone, or certain other common medications like aspirin, folic acid, or some antibiotics. Other health conditions such as certain types of cancer, untreated issues with your womb lining, a history of blood clots, severe heart or kidney problems, or active stomach ulcers would also exclude you from participating.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 35 years old?
Have you been diagnosed with endometriosis and/or adenomyosis?
Do you have a frozen embryo (blastocyst) ready for transfer after IVF?
Is your womb considered normal by your doctor?
Are you able to have an MRI scan?
Are you not allergic to any of the study medications, including the GnRH agonist or standard IVF hormones?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will first have an MRI scan to confirm your diagnosis. You will then receive your usual hormone support (oestrogens and progestins) as planned for your frozen embryo transfer. In addition to this, you will either receive one or two injections of the GnRH agonist (Decapeptyl 3mg) about one month before your planned embryo transfer, or you will only receive the standard hormone support. The study will monitor how well the embryo implants and whether pregnancy occurs. The exact number of visits and follow-up will be discussed with you, but the main treatments involve the injections and the embryo transfer, with follow-up to check for pregnancy. The total duration of your active participation would cover the month leading up to your transfer and the subsequent pregnancy test.

Potential risks and benefits

Through taking part in this study, you might personally benefit if the GnRH agonist injection proves to increase your chances of pregnancy. Even if it doesn't directly help you, your participation will provide valuable information that could help other women with endometriosis or adenomyosis in the future. As with all medications, there's always a chance of side effects from the GnRH agonist or other study medications, which will be fully explained to you. You are free to withdraw from the study at any time without giving a reason, and this decision will not affect your future medical care.

Locations (1)

Hopital Foch
Verified postcode
Suresnes, France· Recruiting

Common questions

What is an 'embryo transfer'?

An embryo transfer is a step in IVF where a fertilised egg (embryo) is placed back into your womb to try and achieve a pregnancy.

What is a 'GnRH agonist'?

A GnRH agonist is a type of hormone medicine that helps reduce inflammation and can create a better environment in the womb for an embryo to implant.

Who can join this study?

This study is for women aged 18-35 with endometriosis or adenomyosis who are planning a frozen embryo transfer, providing they meet other health criteria.

Will I definitely receive the new treatment?

This is a comparison study, so some participants will receive the GnRH agonist injection along with standard care, while others will receive standard care only. You won't know which group you're in.

What if I change my mind after joining?

You are free to leave the study at any time, for any reason, without it affecting your medical care.

How to find out more

Elisabeth Hulier-Ammar, Dr

e.hulier-ammar@hopital-foch.com 0033146251175 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.