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: 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 10014787Term: Endometriosis of uterusSystem 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-AT

Lead Sponsor: Ferring Pharmaceuticals A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

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 response in a long GnRH agonist protocol versus a GnRH antagonist protocol;Secondary Objective: • To evaluate the effect of individualised FE 999049 treatment on other pharmacodynamic parameters in a long GnRH agonist protocol versus a GnRH antagonist protocol<br>• To evaluate the effect of individualised FE 999049 treatment on pregnancy rates in a long GnRH agonist protocol versus a GnRH antagonist protocol<br>• To evaluate the safety of individualised FE 999049 treatment in a long 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

Secondary Outcome Measures

Name	Time	Method

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