A Comparison of Letrozole and Clomifene Citrate

Sponsor

The University of Hong Kong (Other)

Overall Status

Unknown status

CT.gov ID

NCT02647424

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Polycystic ovary syndrome (PCOS) is one of the most common endocrinopathies, affecting 5% to 10% of women of reproductive age. Women with PCOS suffer from anovulatory infertility. Following lifestyle modification with weight reduction in obese PCOS women, clomifene citrate (CC) is considered the first line treatment for ovulation induction (OI) in these women. 75-80% of women will ovulate after CC administration. However, there is a discrepancy between the ovulation rate and pregnancy rate, which was reported to be 22% per each ovulating cycles after CC. Other alternatives, including gonadotropin injections and laparoscopic ovarian drilling, carried different disadvantages, such as costly treatment and risks of ovarian hyperstimulation syndrome and multiple pregnancy rate in gonadotrophin therapy and surgical risks and risk of ovarian failure in surgical treatment.

The use of aromatase inhibitor, letrozole (LTZ), in reproductive medicine started in 2001. After this publication, there have been many groups of investigators studying the use of LTZ either in OI or ovarian stimulation in IVF cycles. A large multicentre randomized trial reported a significantly higher ovulation rate and live-birth rate comparing LTZ with CC. In majority of the publications, the multiple pregnancy rate was lower in LTZ group than in CC group. This can be attributed to the higher chance of monofollicular development after LTZ compared with CC. However, there is no information comparing the hormonal profile and follicular development after letrozole and CC.

Mild ovarian stimulation using LTZ or CC in conjunction with intrauterine insemination is commonly offered to ovulatory women with unexplained infertility, minimal endometriosis or mild factor to improve the pregnancy rate. There is again no information comparing the hormonal profile and follicular development after letrozole and CC in ovulatory women.

The aim of this study is to compare the hormonal profile after the use of LTZ and CC in anovulatory PCOS women and ovulatory women with unexplained subfertility. The hypothesis is that the FSH risk after LTZ is shorter than that of CC.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovarian Syndrome Subfertility	Drug: Letrozole Drug: Clomiphene	N/A

Detailed Description

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Comparison of Hormonal Profile and the Follicular Development Between Letrozole and Clomifene Citrate in Anovulatory Women With Polycystic Ovary Syndrome and Ovulatory Women

Study Start Date :

Dec 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: PCOS group PCOS women with anovulation	Drug: Letrozole Letrozole 2.5 mg daily from Day 2 to 6 Other Names: Letrozole group Drug: Clomiphene After one month of washout period, clomiphene 50 mg daily from day 2 to day 6 given Other Names: Clomiphene group
Other: Ovulatory group Ovulatory group planned for intra-uterine insemination	Drug: Letrozole Letrozole 2.5 mg daily from Day 2 to 6 Other Names: Letrozole group Drug: Clomiphene After one month of washout period, clomiphene 50 mg daily from day 2 to day 6 given Other Names: Clomiphene group

Arm

Intervention/Treatment

Other: PCOS group

PCOS women with anovulation

Drug: Letrozole

Letrozole 2.5 mg daily from Day 2 to 6

Other Names:

Letrozole group

Drug: Clomiphene

After one month of washout period, clomiphene 50 mg daily from day 2 to day 6 given

Other Names:

Clomiphene group

Other: Ovulatory group

Ovulatory group planned for intra-uterine insemination

Drug: Letrozole

Letrozole 2.5 mg daily from Day 2 to 6

Other Names:

Letrozole group

Drug: Clomiphene

After one month of washout period, clomiphene 50 mg daily from day 2 to day 6 given

Other Names:

Clomiphene group

Outcome Measures

Primary Outcome Measures

FSH concentrations [Alternative day during ovulation induction cycle (for about 3 month)]

Secondary Outcome Measures

LHconcentration [Alternative day during ovulation induction cycles (for about 3 month)]
Endometrial Thickness [Monitoring during ovulation induction cycle (for about 3 month)]
Oestradiol concentration [Alternative day during ovulation induction cycles (for about 3 month)]
Progesterone concentration [Alternative day during ovulation induction cycles (for about 3 month)]
Number of growing follicles [Monitoring during OI cycles (for about 3 month)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 39 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion criteria:

Age of women 18-39 years
Irregular menstrual cycles with anovulation (cycle >35 days) together with polycystic ovaries on pelvic scanning or laboratory/clinical hyperandrogenism (in PCOS group)
Regular cycle of 25-35 days cycle for the ovulatory women group
Body mass index </= 30 kg/m2