MENOPUR and REKOVELLE in Women UnderGoing an assisted reproductive technology cycle

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Ferring Pharmaceuticals A/S

Participant type

Patients

Age range

18-64 years

Gender

Female

Therapeutic area

Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]

Decision date (initial)

2022-11-09

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Ferring Pharmaceuticals A/S · Ferring Pharmaceuticals A/S

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To compare the ovarian response after controlled ovarian stimulation with different mixed protocols of REKOVELLE and MENOPUR

Secondary objectives 4

1. To evaluate the follicular development and endocrine profile associated with different mixed protocols of REKOVELLE and MENOPUR
2. To describe the embryo development associated with different mixed protocols of REKOVELLE and MENOPUR To describe the treatment efficiency associated with different mixed protocols of REKOVELLE and MENOPUR To describe the safety profile associated with different mixed protocols of REKOVELLE and MENOPUR
3. To describe the treatment efficiency associated with different mixed protocols of REKOVELLE and MENOPUR
4. To describe the safety profile associated with different mixed protocols of REKOVELLE and MENOPUR

Conditions and MedDRA coding

Infertility in women undergoing assisted reproductive technologies (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Informed Consent Form signed prior to screening evaluations.
2. In good physical and mental health as judged by the investigator, and willing and able to comply with the trial protocol.
3. Pre-menopausal females between the ages of 18 and 40 years. The subjects must be at least 18 years (including the 18th birthday) when they sign the informed consent and no more than 40 years (up to the day before the 41st birthday) at the time of randomisation.
4. Infertile women diagnosed with tubal infertility, unexplained infertility, endometriosis stage I/II or with partners diagnosed with male factor infertility, eligible for in vitro fertilisation (IVF) and/or intracytoplasmic sperm injection (ICSI) using fresh or frozen ejaculated sperm from male partner or sperm donor.
5. Infertility for at least one year before randomisation for subjects ≤37 years or for at least 6 months for subjects ≥38 years (not applicable in case of tubal or severe male factor infertility).
6. Regular menstrual cycles of 21-35 days (both inclusive), presumed to be ovulatory.
7. Transvaginal ultrasound documenting presence and adequate visualisation of both ovaries, without evidence of significant abnormality (e.g. no endometrioma greater than 3 cm, and no enlarged ovaries or ovarian cyst not due to polycystic ovarian syndrome, which would contraindicate the use of gonadotropins) and normal adnexa (e.g. no hydrosalpinx) within 1 year prior to randomisation. Both ovaries must be accessible for oocyte retrieval.
8. Early follicular phase (cycle day 2-4) serum levels of FSH between 1 and 15 IU/L (results obtained within 3 months prior to randomisation).

Exclusion criteria 17

1. Primary ovarian failure.
2. Known endometriosis stage III-IV.
3. Considered unsuitable for controlled ovarian stimulation with a dosing regimen corresponding to approximately 225 IU/day gonadotropin, as judged by the investigator.
4. History of previous episode of OHSS or exuberant ovarian response to gonadotropins, and polycystic ovarian syndrome.egnancy.
5. One or more follicles ≥10 mm (including cysts) observed on the transvaginal ultrasound prior to randomisation on stimulation day 1 (puncture of cysts is allowed prior to randomisation).
6. Any known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) which can compromise participation in the trial with the exception of controlled thyroid function disease.
7. Known tumours of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus which would contraindicate the use of gonadotropins.
8. Fibroid tumours of the uterus incompatible with pregnancy.
9. Active arterial or venous thromboembolism.
10. Currently breast-feeding.
11. Undiagnosed vaginal bleeding.
12. Findings at the gynaecological examination at screening which preclude gonadotropin stimulation or are associated with a reduced chance of pregnancy, e.g. congenital uterine abnormalities or retained intrauterine device.
13. Pregnancy (negative urinary pregnancy tests must be documented at screening and prior to randomisation) or contraindication to pregnancy.e exception of controlled thyroid function disease.
14. Use of fertility modifiers during the last menstrual cycle before randomisation, including dehydroepiandrosterone (DHEA) or cycle programming with oral contraceptives, progestogen or estrogen preparations.ns.
15. Hypersensitivity to any active ingredient or excipients in the medicinal products used in the trial.
16. Previous participation in the trial.
17. Use of any non-registered investigational drugs during the last 3 months prior to randomisation.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Number of fertilised (2 pronuclei [2PN]) oocytes at 19±2 hours after insemination

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Auxiliary 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Ferring Pharmaceuticals A/S

Sponsor organisation

Ferring Pharmaceuticals A/S

Address

Amager Strandvej 405

City

Kastrup

Postcode

2770

Country

Denmark

Scientific contact point

Organisation

Ferring Pharmaceuticals A/S

Contact name

Sarah Grover

Public contact point

Organisation

Ferring Pharmaceuticals A/S

Contact name

Global Translational & Clinical R&D

Locations

2 EU/EEA countries · 4 investigational sites

By country

Investigational sites

Application history

1 submissions — initial application plus substantial / non-substantial modifications