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

Sponsor
Reproductive & Genetic Hospital of CITIC-Xiangya (Other)
Overall Status
Recruiting
CT.gov ID
NCT05227391
Collaborator
(none)
1,078
1
2
33.5
32.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Oral Letrozole
  • Procedure: Oral estradiol valerate
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1078 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Live Birth After Letrozole-stimulated Cycles Versus Hormone Replacement Treatment Cycles for the First Frozen Embryo Transfer in Women With PCOS: a Randomized Controlled Trial
Actual Study Start Date :
Mar 16, 2022
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Letrozole-stimulated group

Procedure: 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.

Active Comparator: Hormone replacement treatment group

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.

Outcome Measures

Primary Outcome Measures

  1. Live birth rate [11 months]

    Number of women with live birth/ number of women randomized to the specific group. Live birth is defined as the delivery of any viable infant at 28 weeks or more of gestation.

Secondary Outcome Measures

  1. Clinical pregnancy rate [2 months]

    Number of women with clinical pregnancy /number of women randomized to the specific group. Clinical pregnancy was defined as the presence of at least one gestational sac in the uterine cavity on ultrasound at about 28 days after embryo transfer.

  2. Biochemical pregnancy rate [1.5 months]

    Number of women with biochemical pregnancy /number of women randomized to the specific group. Biochemical pregnancy was defined as a human chorionic gonadotropin level of more than 10 milli-International unit (mIU) per milliliter (ml) as measured at about 14 days after embryo transfer.

  3. Pregnancy loss rate [9 months]

    Number of women with pregnancy loss / number of women with clinical pregnancy. Pregnancy loss refers to a complete spontaneous abortion or a nonviable pregnancy before 28 weeks of gestation.

  4. Cycle cancellation rate [1 month]

    Number of women with cycle cancellation / number of women randomized to the specific group.

  5. Birth weight [11 months]

    Weight of newborns at delivery.

  6. Incidence of obstetric and perinatal complications [11 months]

    Number of pregnancies with complications / number of clinical pregnancies.

  7. Incidence of neonatal complications [11 months]

    Number of live births with neonatal complications / number of live births.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 38 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
    1. women diagnosed with PCOS according to modified Rotterdam criteria;
    1. Women who are participating in their first cycle of IVF or ICSI.
    1. Women whose IVF/ICSI ovarian stimulation protocol was either GnRH antagonist protocol or long agonist protocol.
    1. Women with whole embryos freezing.
    1. Women aged 20 to 38 years old;
    1. Women BMI 18 kg/m2 to 30 kg/m2
    1. 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.
    1. Women with unilateral/bilateral oophorectomy.
    1. Women with untreated Hydrosalpinx.
    1. 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.
    1. Women with uncontrolled diabetes mellitus, thyroid disease and hypertension.
    1. Women who are indicated and planned to undergo preimplantation genetic test (PGT).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Reproductive & Genetic Hospital of CITIC-Xiangya Changsha Hunan China 410000

Sponsors and Collaborators

  • Reproductive & Genetic Hospital of CITIC-Xiangya

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Reproductive & Genetic Hospital of CITIC-Xiangya
ClinicalTrials.gov Identifier:
NCT05227391
Other Study ID Numbers:
  • P2022001
First Posted:
Feb 7, 2022
Last Update Posted:
Apr 21, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 21, 2022