A trial to compare the efficacy and safety of individualised FE 999049 (follitropin delta) dosing in women undergoing controlled ovarian stimulatio

Phase 1

• Conditions: Infertility in women undergoing assisted reproductive technologies (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle; MedDRA version: 21.0Level: LLTClassification code 10014787Term: Endometriosis of uterusSystem Organ Class: 100000004872; MedDRA version: 20.1Level: LLTClassification code 10016398Term: Female infertilitySystem Organ Class: 100000004872; MedDRA version: 21.0Level: LLTClassification code 10016403Term: Female infertility of tubal originSystem Organ Class: 100000004872; MedDRA version: 21.1Level: LLTClassification code 10025511Term: Male infertility, unspecifiedSystem Organ Class: 100000004872; MedDRA version: 21.0Level: LLTClassification code 10014784Term: Endometriosis of ovarySystem Organ Class: 100000004872; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2017-002783-40-IT
• Lead Sponsor: Ferring Pharmaceutical A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-22
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

1.Informed Consent Documents signed prior to screening evaluations.
2.In good physical and mental health.
3.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 <
38 years or for at least 6 months for subjects =38 years (not applicable
in case of tubal or severe male factor infertility).
6.The trial cycle will be the subject's first controlled ovarian
stimulation cycle for IVF/ICSI.
7.Regular menstrual cycles of 24-35 days (both inclusive), presumed
to be ovulatory.
8.Hysterosalpingography, hysteroscopy, saline infusion sonography, or
transvaginal ultrasound documenting a uterus consistent with expected
normal function (e.g. no evidence of clinically interfering uterine fibroids
defined as submucous or intramural fibroids larger than 3 cm in
diameter, no polyps and no congenital structural abnormalities which are
associated with a reduced chance of pregnancy) within 1 year prior to
randomisation.
9.Transvaginal ultrasound documenting presence and adequate
visualisation of both ovaries, without evidence of significant abnormality
(e.g. no endometrioma greater than 2 cm or enlarged ovaries 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.
10.Early follicular phase (cycle day 2-5) serum levels of FSH between 1
and 15 IU/L at screening.
11.Negative serum Hepatitis B Surface Antigen (HBsAg), Hepatitis C
Virus (HCV) and Human Immunodeficiency Virus (HIV) antibody tests
within 1 year prior to randomisation.
12.Body mass index (BMI) between 17.5 and 32.0 kg/m2 (both
inclusive) at screening.
13.If < 38 years willing to accept single blastocyst transfer. If =38
years willing to accept transfer of a single good-quality blastocyst
(double blastocyst transfer may be performed if no good-quality
blastocyst is available).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.AMH >35 pmol/L at screening.
2.Strong preference of the subject for either treatment protocol.
3.Known endometriosis stage III-IV (defined by the revised American
Society for Reproductive Medicine [ASRM] classification, 1996).
4.Known history of recurrent miscarriage (defined as three consecutive
losses after ultrasound confirmation of pregnancy (excl. ectopic
pregnancy) and before week 24 of pregnancy).
5.Known abnormal karyotype of subject or of her partner / sperm
donor, as applicable, depending on source of sperm used for
insemination in this trial.
6.Any known clinically significant systemic disease (e.g. insulin-
dependent diabetes).
7.Known inherited or acquired thrombophilia disease.
8.Active arterial or venous thromboembolism or severe
thrombophlebitis, or a history of these events.
9.Known porphyria.
10.Any known endocrine or metabolic abnormalities (pituitary,
adrenal, pancreas, liver or kidney) with the exception of controlled
thyroid function disease.
11.Known tumours of the ovary, breast, uterus, adrenal gland,
pituitary or hypothalamus which would contraindicate the use of
gonadotropins.
12.Known moderate or severe impairment of renal or hepatic function.
13.Currently breast-feeding.
14.Undiagnosed vaginal bleeding.
15.Known abnormal cervical cytology of clinical significance observed
within 3 years prior to randomisation (unless the clinical significance has
been resolved).
16.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.
17.Pregnancy (negative pregnancy test must be documented at
screening) or contraindication to pregnancy.
18.Known current active pelvic inflammatory disease.
19.Use of fertility modifiers during the last menstrual cycle before
randomisation, including dehydroepiandrosterone (DHEA), metformin or
cycle programming with oral contraceptives, progestogen or estrogen
preparations.
20.Use of hormonal preparations (except for thyroid medication)
during the last menstrual cycle before randomisation.
21.Known history of chemotherapy (except for gestational conditions)
or radiotherapy.
22.Current or past (1 year prior to randomisation) abuse of alcohol or
drugs and/or current (last month) intake of more than 14 units of
alcohol per week.
23.Current or past (3 months prior to randomisation) smoking habit of
more than 10 cigarettes per day.
24.Hypersensitivity to any active ingredient or excipients in the
medicinal products used in the trial.
25.Previous participation in the trial
26.Use of any non-registered investigational drugs during the last 3
months prior to randomisation.
See also Withdrawal Criteria in the study protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effect of individualised FE 999049 treatment on ovarian <br>response in a long GnRH agonist protocol versus a GnRH antagonist <br>protocol;Secondary Objective: • To evaluate the effect of individualised FE 999049 treatment on other <br>pharmacodynamic parameters in a long GnRH agonist protocol versus a <br>GnRH antagonist protocol<br>• To evaluate the effect of individualised FE 999049 treatment on <br>pregnancy rates in a long GnRH agonist protocol versus a GnRH <br>antagonist protocol<br>• To evaluate the safety of individualised FE 999049 treatment in a long <br>GnRH agonist protocol versus a GnRH antagonist protocol;Primary end point(s): Number of oocytes retrieved;Timepoint(s) of evaluation of this end point: Oocyte retrieval will take place 36h (±2h) after triggering of final follicular maturation