etrozole Or Clomifene for Ovulation Inductio

Phase 1

• Conditions: Ovulation induction for women suffering from polycystic ovary syndrome; MedDRA version: 20.0Level: LLTClassification code 10002658Term: AnovulationSystem Organ Class: 100000004860; MedDRA version: 20.0Level: LLTClassification code 10021935Term: Infertility, female, associated with anovulationSystem Organ Class: 100000004872; MedDRA version: 21.1Level: LLTClassification code 10036050Term: Polycystic ovarySystem Organ Class: 100000004872; MedDRA version: 20.0Level: PTClassification code 10049550Term: Live birthSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2018-004641-16-GB
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-19
• Last Update Posted: 4 May 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 2100

Inclusion Criteria

?Women diagnosed with PCOS (according to Rotterdam criteria)13 and evidence of anovulation (anovulation is defined as irregular cycles lasting <21 or more than 35 days or less than 8 periods per year OR absence of raised serum progesterone greater than 20nmol/l 7 days prior to a period);
?Presentation with infertility or wishing to conceive;
?Male partner with normal sperm count (= 15 million) and progressive motility (= 32%) in the last 3 years;
?Willing and able to give informed consent.

Are the trial subjects under 18? yes
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 2100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

?Age =18 or =43 years at randomisation;
?Body Mass Index =35;
?Three or more previous ovulation induction treatments with either letrozole or clomifene;
?Intention to continue current use of metformin treatment or inositol supplements for ovulation induction or for other indications
?Metformin or inositol supplement use in the previous 3 months
?Women opting for alternative methods of ovulation induction or treatment (GnRH agonists and antagonists, gonadotropins), triggering ovulation with hCG, or performing intrauterine or intracervical insemination;
?Contraindications to letrozole, clomifene, metformin use and/or pregnancy (see section 7.3 for full details on contraindications).
?Woman has previously participated in the LOCI trial.

Study & Design

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