Live Birth After Letrozole-stimulated Cycles Versus Hormone Replacement Treatment Cycles for the First Frozen Embryo Transfer in Women With PCOS

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

1078 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-16

Study Completion Date

2024-12-31

Brief Summary

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This is a multicenter randomized controlled trial comparing the efficacy and safety of two endometrial preparation protocols for the first frozen embryo transfer cycle in PCOS with whole embryo freezing. Subjects will be randomized to letrozole-stimulated group or hormone replacement treatment group in their first frozen embryo transfer cycle, and their pregnancy and perinatal outcomes during this cycle will be followed up and analysis.

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Detailed Description

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Conditions

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PCOS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Letrozole-stimulated group

Group Type EXPERIMENTAL

Oral Letrozole

Intervention Type PROCEDURE

Oral Letrozole at a dose of 2.5mg daily will be started on days 3-5 of the menstrual cycle and will be continued for 5 days.

Hormone replacement treatment group

Group Type ACTIVE_COMPARATOR

Oral estradiol valerate

Intervention Type PROCEDURE

Oral estradiol valerate at a dose of 3mg twice daily will be started on days 3-5 of the menstrual cycle.

Interventions

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Oral Letrozole

Oral Letrozole at a dose of 2.5mg daily will be started on days 3-5 of the menstrual cycle and will be continued for 5 days.

Intervention Type PROCEDURE

Oral estradiol valerate

Oral estradiol valerate at a dose of 3mg twice daily will be started on days 3-5 of the menstrual cycle.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 1\. women diagnosed with PCOS according to modified Rotterdam criteria;
* 2\. Women who are participating in their first cycle of IVF or ICSI.
* 3\. Women whose IVF/ICSI ovarian stimulation protocol was either GnRH antagonist protocol or long agonist protocol.
* 4\. Women with whole embryos freezing.
* 5\. Women aged 20 to 38 years old;
* 6\. Women BMI 18 kg/m2 to 30 kg/m2
* 7\. Women with at least one good-quality embryo suitable for transfer, including day 3 cleavage stage embryo with grade 7CI /8CI and day 5 or day 6 blastocyst with grade 4BB or higher.

Exclusion Criteria

* 1\. Women who has a history of recurrent spontaneous abortion.
* 2\. Women with unilateral/bilateral oophorectomy.
* 3\. Women with untreated Hydrosalpinx.
* 4\. Women with a uterine cavity abnormality, such as a uterine congenital malformation, untreated uterine septum (except shallow uterine septum), adenomyosis, submucous myoma, or moderate to severe intrauterine adhesions.
* 5\. Women with uncontrolled diabetes mellitus, thyroid disease and hypertension.
* 6\. Women who are indicated and planned to undergo preimplantation genetic test (PGT).

Minimum Eligible Age

20 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No