Purified urinary follicle stimulating hormone (FSH) and recombinant FSH follitropin-alpha for polycystic ovarian syndrome (PCOS) patients undergoing intra-cytoplasmic sperm injection (ICSI)

Prospective randomised study comparing purified urinary follicle stimulating hormone (FSH) (Fostimon®) and recombinant FSH Follitropin-alpha (Gonal-f®) for polycystic ovarian syndrome (PCOS) patients undergoing intra-cytoplasmic sperm injection (ICSI)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN36808716

Enrollment

Registered

2009-07-21

Start date

2008-11-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic ovarian syndrome Nutritional, Metabolic, Endocrine Ovarian dysfunction

Interventions

After the gonadotropin releasing hormone analogue (GnRHa) protocol a start dose of 2 - 3 ampoules of FSH (purified urinary FSH [Fostimon®] or recombinant FSH Follitropin-alpha [Gonal-f®]), depending o

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 37 years, female 2. Body mass index (BMI) 19 - 32 kg/m^2 3. FSH below 10 4. World Health Organization (WHO) group II women with PCOS (Roterdam criteria) 5. Indication for ICSI as male factor, tubal factor, long standing infertility not responding to other lines of treatment in PCOS patients

Exclusion criteria

Exclusion criteria: 1. Previous failed IVF/ICSI 2. General medical disorders, diabetes, hypertension, thyroid disturbance, or hyperprolactinemia 3. Intrauterine lesions or fibroids 4. Non-obstructive azoospermia

Design outcomes

Primary

Measure	Time frame
Measured on day of oocyte retrieval: 1. Number and percentage of mature oocytes 2. Quality of oocytes	—

Secondary

Measure	Time frame
Measured from day of embryo transfer up to 7 weeks: 1. Number of grade I embryos 2. Implantation rate 3. OHSS rate 4. Number of ampoules of FSH	—

Countries

Egypt

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026