The Effectiveness of Clomiphene Citrate In suppression of Luteinising Hormone (LH) Surge in Assisted Reproductive Technologies (ART): A randomized controlled pilot study

The effectiveness of Clomiphene Citrate compared to Human Menopausal Gonadotrophon on the suppression of Luteinising Hormone surges in women undergoing ovulation induction

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000568415

Enrollment

120

Registered

2007-11-05

Start date

2007-11-01

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

Brief summary

Clomiphene citrate (CC) is traditionally given from the 3rd-5th day of the cycle for five days as an ovulation induction drug. The mechanism of CC in stimulating ovulation is unknown but is believed to be related to its anti-oestrogenic properties. As a feed back mechanism, it stimulates the secretion of follicle stimulating hormone (FSH). When serum estradiol reaches a certain level, an leutinizing hormone (LH) surge is released. Of the cycles stimulated by CC and or human menopausal gonadotrophin (hMG), an endogenous LH surge was observed in more than 15% of the patients shortly prior to the HCG injection. In animal experimental studies, CC prevented the positive effects of estradiol required to induce an LH surge. In a recent pilot study by Branigan & Estes 2006, CC was able to suppress LH surge in human IVF. The hypothesis behind this study is that if CC is given after hMG, the anti-oestrogenic effect will suppress LH surge.

Interventions

- Participants will receive a fixed dose of intramuscular/ subcutaneous Human Menopausal Gonadotropin (hMG) 75-150 IU per day starting from day 3 of the menstrual cycle for four days, then participants will receive oral Clomiphene Citrate (CC) till follicle reach 20mm - All participants will undergo monitoring by ultrasound from day 8 and daily serum Luteinising Hormone (LH) when leading follicle is more than 15mm - E2 assay will be done on day of Human Chorionic Gonadotropin (hCG) - Progestero

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 38 Years

Healthy volunteers

Yes

Inclusion criteria

-mild male factor -less than 39 years of age - Normal uterus as documented by ultrasound (US) examination - healthy females as documented by examination and laboratory tests

Exclusion criteria

- Subfertility due to other causes - Any significant cardiovascular, pulmonary, neurologic, allergic, hepatic or renal disease - Any laboratory parameter clinically relevant outside the normal range - No ovarian cyst formation >2cm prior to start of stimulation - Women with Body Mass Index (BMI) > 30 - Women with Polycystic Ovary (PCO) Syndrome

Outcome results