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Sequential letrozole and human menopausal gonadotropins (HMG) : The effect of a novel super ovulation protocol on pregnancy rate in polycystic ovarian syndrome patients undergoing intracytoplasmic sperm injection. Randomized Controlled Trial

Sequential administration of letrozole and Human Menopausal gonadotropins (HMG) improves the pregnancy rate in polycystic ovarian syndrome ( PCOS) patients treated with intracytoplasmic sperm injection ( ICSI ) – a randomized controlled trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000025639
Enrollment
40
Registered
2014-01-09
Start date
2014-01-15
Completion date
2016-01-08
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

a new induction protocol for polycyctic ovary syndrome patients complaining of inability to concieve that hopefully will lead to improvement of pregnancy rate

Interventions

Induction of ovulation will be done by letrozole tablets 5 mg mg /day from day 2 to day 6 of the participant's menstrual cycle then human menopausal gonadotropins ( HMG ) ampoules (fostimon ;IBSA) ( 150-225 IU /day ) will be given intramuscular according to patients response started from day 7 of menstrual follow till the day of human chorionic gonadotropin (HCG) -which is a hormone similar to endogenous lutienizing hormone to trigger ovulation-in a dose of 10000 iu intramuscular when

Induction of ovulation will be done by letrozole tablets 5 mg mg /day from day 2 to day 6 of the participant's menstrual cycle then human menopausal gonadotropins ( HMG ) ampoules (fostimon ;IBSA) ( 150-225 IU /day ) will be given intramuscular according to patients response started from day 7 of menstrual follow till the day of human chorionic gonadotropin (HCG) -which is a hormone similar to endogenous lutienizing hormone to trigger ovulation-in a dose of 10000 iu intramuscular when the dominant follicle reaches 17 mm . ovum pick up for Intracytoplasmic sperm injection (ICSI ) will be done 34-36 hours after HCG adminstration.

Sponsors

alexandria university , faculty of medicine
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
20 Years to 35 Years
Healthy volunteers
No

Inclusion criteria

PCOS complaining of infertility age between 20-35 years. normal semen analysis according to WHO criteria

Exclusion criteria

female with a previous history of pelvic surgery endometriosi. females with a previous history of failed ICSI

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026