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A Comparison of Letrozole and Clomifene Citrate

NCT ID: NCT02647424

Last Updated: 2016-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Polycystic Ovarian Syndrome Subfertility

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PCOS group

PCOS women with anovulation

Group Type OTHER

Letrozole

Intervention Type DRUG

Letrozole 2.5 mg daily from Day 2 to 6

Clomiphene

Intervention Type DRUG

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

Ovulatory group

Ovulatory group planned for intra-uterine insemination

Group Type OTHER

Letrozole

Intervention Type DRUG

Letrozole 2.5 mg daily from Day 2 to 6

Clomiphene

Intervention Type DRUG

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

Interventions

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Letrozole

Letrozole 2.5 mg daily from Day 2 to 6

Intervention Type DRUG

Clomiphene

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

Intervention Type DRUG

Other Intervention Names

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Letrozole group Clomiphene group

Eligibility Criteria

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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

Exclusion Criteria

* Couples undergoing ART treatment cycles
* History of ovarian surgery
* Drug allergy to CC or LTZ
* History of diabetes mellitus or other severe medical diseases
* Refusal to join the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vivian Lee, MBBS, MRCOG

Role: PRINCIPAL_INVESTIGATOR

Queen Mary Hospital / University of Hong Kong.

Locations

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Queen Mary Hospital

Hong Kong, Hong Kong, Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Vivian Lee, MBBS, MRCOG

Role: CONTACT

Phone: 22553400

Email: [email protected]

Facility Contacts

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Vivian CY Lee, MBBS

Role: primary

Other Identifiers

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HKU-VL-LCC

Identifier Type: -

Identifier Source: org_study_id