A comparison of two types of follicle stimulating hormone during fertility treatment.

Phase 1

• Conditions: Female infertility.; MedDRA version: 14.1Level: LLTClassification code 10016398Term: Female infertilitySystem Organ Class: 100000004872; MedDRA version: 14.1Level: LLTClassification code 10016399Term: Female infertility (primary)System Organ Class: 100000004872; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2013-002482-19-GB
• Lead Sponsor: IBSA Institut Biochimique SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-10-14
• Study Completion: 2017-08-12
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 710

Inclusion Criteria

- Able and willing to sign the Subjcet Consent Form and adhere to the study visitation schedule;
- >/18 and <39 years old;
- BMI: =18 and =28 kg/m2;
- Less than 3 previously completed IVF cycles (i.e. completed cycle = egg recovery);
- Basal FSH <10 IU/L and E2 <80 pg/ml (~290 pmol/l);
- TSH < 2.5 mIU/L
- >10 antral follicles 2-10 mm in size for both ovaries combined (measured day 2-4 of menstrual cycle)
- AMH > 1 ng/ml (7.15 pmol/l) and < 4 ng/ml (28.6 pmol/l)
- Presence and adequate visualisation of both ovaries;
- Within 12 months of the beginning of the study, uterine cavity consistent with expected normal function as assessed through transvaginal ultrasound, hysterosalpingogram, sonohysterogram or hysteroscopic examination.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 720
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

- Age <18 and = 39 years;
- Primary ovarian failure or women known as poor responders (according to the Bologna criteria1);
- PCO & PCOS (according to Rotterdam criteria);
- Severe OHSS in a previous COH cycle;
- Uterine malformation that may impair the possibility to get pregnant;
- Ovarian cysts >10 mm;
- Hydrosalpinx that have not been surgically removed or ligated;
- Endometriosis stage 3 or 4;
- Oocyte donation;
- Severe male factor
- Patients affected by pathologies associated with any contraindication of being pregnant;
- History of recurrent miscarriage (i.e. more then 3 previous miscarriages);
- Hypersensitivity to the study medication;
- Abnormal bleeding of undetermined origin;
- Uncontrolled thyroid or adrenal dysfunction;
- Neoplasias;
- Severe impairment of renal and/or hepatic function;
- Use of concomitant medications that might interfere with study evaluations (e.g. non-study hormonal medications, prostaglandin inhibitors, psychotropic agents).

Study & Design

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