ADAPT-1
Research type
Research Study
Full title
A randomised, controlled, assessor-blind, parallel groups, multicentre, multinational trial comparing the ovarian response of a starting dose of 15 µg follitropin delta (REKOVELLE) to a starting dose of 225 IU follitropin alfa (GONAL-F) in conventional regimens in controlled ovarian stimulation in women undergoing an assisted reproductive technology programme
IRAS ID
1004522
Contact name
Rita Lobo
Contact email
Sponsor organisation
Ferring Pharmaceuticals A/S
Eudract number
2021-001785-38
Clinicaltrials.gov Identifier
Research summary
This is a randomised, controlled, assessor-blind, parallel groups, multicentre, multinational study comparing a starting dose of 15 µg REKOVELLE to a starting dose of 225 IU GONAL F in conventional regimens with respect to ovarian response in women undergoing controlled ovarian stimulation. This purpose of this research is to provide more knowledge about REKOVELLE, including the doses applied in the study.\n\nApproximately 300 participants will be randomly assigned to one of the two treatment groups; controlled ovarian stimulation with REKOVELLE or controlled ovarian stimulation with GONAL F. Participants will have double chances to be randomised to the REKOVELLE group than the GONAL-F group. The study is planned to take place in approximately 15-20 sites across 3-6 European countries. \n\nParticipants can be treated with REKOVELLE or GONAL-F for a maximum of 20 days. Participants assigned to REKOVELLE, will start with a daily dose of 15 µg which can be decreased or increased by 5 µg after the first four stimulation days according to the study doctor’s recommendation. Participants assigned to GONAL-F, will start with a daily dose of 225 IU which can be decreased or increased by 75 IU after the first four stimulation days according to the study doctor’s recommendation. Either REKOVELLE or GONAL F must be administered as daily subcutaneous (under the skin) injections in the abdominal area using a pre-filled pen.\n\nThe participants will visit the study site, where they will undergo procedures such as medical history, infertility history, gynaecological examinations, transvaginal ultrasounds, blood and urine tests, oocyte retrieval and a physical examination including weight and height. The study doctor will also review previous/current medications.\n\nThis study is sponsored by Ferring Pharmaceuticals A/S.
Why is this study important?
Many couples have difficulties getting pregnant for different reasons. The condition is called infertility. Treatments like the so-called in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) may help and lead to a pregnancy.
One important step of an IVF or ICSI treatment is that the woman takes medicine that helps her body grow eggs. These eggs are then taken outside of the body. To finalise the treatment, an egg and sperm are merged outside the body, and the fertilised egg, the embryo, is placed in the uterus, which is where babies develop. REKOVELLE is a medicine that helps women's bodies grow eggs. REKOVELLE is already approved in Europe. This study helps to further understand how well REKOVELLE works.
What did the researchers want to learn? –
There are several medicines on the market that could be used to help women’s bodies grow eggs and there are different ways in which such medicines are dosed. On the one hand, REKOVELLE is prescribed by tailoring the dose to each woman based on the woman’s weight and the levels of a certain hormone (called anti-Müllerian hormone). The dose stays the same during the several days that women take the medicine. On the other hand, other medicines on the market usually use a different way of dosing: Physicians decide the dose based on the woman’s traits (for example age, body-mass index, anti-Müllerian hormone) and her earlier fertility treatments. The physician might increase or decrease the dose after a few days based on how the woman responds to the treatment. An example for a medicine that can be dosed in such a way is GONAL-F. In this study, the researchers wanted to understand if REKOVELLE worked as well as GONAL-F when using the same way of dosing, which means when using an initial dose that can be adjusted after a few days. To do this, the researchers compared the number of eggs taken from the women who took REKOVELLE with those who took GONAL-F.
When and where did the study take place?
The study started in August 2022 and finished in April 2024. It took place in 5 countries in Europe.
Who took part in this study?
A total of 300 women participated in the study. The women were between 18 and 40 years old. They or their partners had infertility problems, and the women were suitable for fertility treatments like IVF.
Which medicines were studied?
This study compared REKOVELLE with GONAL-F. Similar to REKOVELLE, GONAL-F is an approved medicine that can be used to help women’s bodies grow eggs. About the study medicine - REKOVELLE is a medicine that helps women's bodies grow eggs. It is developed as a treatment for infertility.
How was the study medicine given?
The study participants injected the study medicine under the skin. The dose was 15 µg of REKOVELLE or 225 IU (international units) of GONAL-F once daily for several days. REKOVELLE and GONAL-F are measured in different units, which cannot be compared directly. The doses of REKOVELLE and GONAL-F could be adjusted based on how the women responded to the treatment.
How was this study done?
The study was assessor-blind, which means that the researchers did not know which treatment the participant was getting until the end of the study. Some studies are done this way because knowing which treatment the participants get could affect the researchers’ judgement. Participants were split by chance into 2 groups. One group took REKOVELLE, and the other group took GONAL-F.
The researchers then compared how many eggs were collected from each group after the treatment. The researchers also monitored whether the participants had side effects.
What were the main results of this study?
The results showed that the number of eggs collected from women who took REKOVELLE was similar to the number collected from women who took GONAL-F. Please note, this is the main result of this study. The results from this study may not represent all knowledge about the medicine studied. Other studies may have different results. Usually, more than one study is carried out to find out how well a medicine works.
What were the side effects?
Side effects are defined as health problems that the study doctor thought might be caused by the study treatment. A side effect is considered serious when it is life-threatening, causes lasting problems, or requires hospital care.
Please note, the side effects summarised here have been noted in this study. Other studies may show different results. The results from many studies are needed to decide if a treatment causes a side effect.
Did any side effects happen during the study?
About 1 in 5 participants had side effects after treatment with the study medicines.
For REKOVELLE, 39 of the 200 participants had side effects. This corresponds to just below 1 in 5 participants (19.5%). For GONAL-F, 22 of the 100 participants had side effects. This corresponds to just above 1 in 5 participant (22.0%).REC name
South Central - Oxford B Research Ethics Committee
REC reference
22/SC/0324
Date of REC Opinion
12 Oct 2022
REC opinion
Further Information Favourable Opinion