Does luteal estradiol supplementation have a role in long agonist cycles?"

In intracytoplasmic sperm injection (ICSI) cases using long gonadotropin releasing hormone (GnRH) agonist protocol, does the use of vaginal etradiol luteal supplementation compared to oral estradiol supplementation or propgesterone alone improve luteal hormonal profile or pregnancy rate?

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000225314

Enrollment

270

Registered

2008-05-01

Start date

2004-08-12

Completion date

Unknown

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

Interventions

Intramuscular (IM) progesterone 100 mg/day starting on day of ET till 8 weeks of gestation + Vaginal application of estradiol valerate tablets 2mg 3 times/day starting on day of embryo transfer (ET) throughout the whole luteal phase. The complete duration of the study is 25 months.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

0 to 37 Years

Healthy volunteers

Inclusion criteria

Women undergoing intracytoplasmic sperm injection due to male factor of infertility using pituitary desensitization by GnRH agonist long protocol

Exclusion criteria

Age > 37 years, body mass index (BMI) < 18 or > 29, irregular menstral cycles, women with single ovary, day 3 serum follicle stimulating hormone (FSH) 9.5 milli international units (mIU)/ml or more, basal antral follicle count 6 or less, 5 or less retreived mature follicles, non availability of good quality embryos and failure to obtain a written consent.

Outcome results