search
Back to results

The Effectiveness of the Letrozole-induced Endometrial Preparation Protocol in Frozen-thawed Embryo Transfer (FET)

Primary Purpose

Letrozole, Infertility, Female

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Letrozole
Sponsored by
International Peace Maternity and Child Health Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Letrozole focused on measuring Frozen-thawed embryo transfer, Letroziole, Endothelial preparation protocol

Eligibility Criteria

undefined - 40 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Women <40 years of age undergoing IVF or ICSI at our reproductive center with a total of ≤3 superovulation cycles , and with ≥2 cleavage embryos or ≥1 blastocyst were cryopreserved. Previous cycles of embryo transfer ≤ 2 and only one transfer cycle with 1-2 embryos per study subject was enrolled. Exclusion Criteria: Patients with chromosomal abnormalities in either spouse, hydrosalpinx, severe endometriosis, adenomyosis, and uterine and uterine cavity organic diseases such as uterine malformations, endometrial polyps, and uterine adhesions; patients who underwent pre-implantation genetic diagnosis (PGT); patients who underwent ICSI using surgically obtained epididymal or testicular spermatozoa; patients with a Body mass index (BMI, = weight/height2 ) > 30 kg/m2; patients with recurrent spontaneous abortions; patients with sequential embryo transfer.

Sites / Locations

  • Yu XiaoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

Letrozole-induced endometrial preparation protocol

Natural cycles endometrial preparation protocol

Hormone replacement cycles endometrial preparation protocol

Arm Description

Starting at D3 of the menstrual cycle, letrozole 2.5 mg po qd was administered for 5 days. After 1 week, ultrasound was performed to dynamically monitor follicular development, and 75-150 IU im qd of human menopausal gonadotrophin (hMG) given to continue ovulation stimulation as needed, and oestradiol valerate 2 mg po qd was given to regulate endometrial thickness until the follicle developed to 16 mm in diameter and 7 mm in endometrial thickness. The follicles developed to ≥16 mm in diameter and ≥7 mm in lining thickness and were dynamically monitored by ultrasound and serum sex hormone levels to determine the day of ovulation. From the day of ovulation, dexamethasone 10 mg po tid was administered, and cleavage-stage embryos were transferred 2 or 3 days later, or blastocysts were transferred 5 days later. Deferiprone 10 mg po tid was continued for 14 days after transfer.

Follicular development was monitored dynamically by ultrasound from D8-D11of the menstrual cycle until the follicles developed to ≥16 mm in diameter and ≥7 mm in endothelial thickness, and the day of ovulation was determined by dynamic ultrasound monitoring and detection of serum sex hormone levels. Deferiprone 10 mg po tid was administered from the day of ovulation, and D2 or D3 cleavage stage embryos were transferred 2 or 3 days later, or blastocysts were transferred 5 days later. Deferiprone 10 mg po tid was continued for a total of 14 days after transfer. Cycles were canceled if endothelial thickness was <7 mm on the day of ovulation or if serum progesterone levels were 5 nmol/L before ovulation.

Starting from D1-D5 of the menstrual cycle, estradiol valerate 2 mg po bid was administered for 7 days, followed by ultrasound for dynamic monitoring of endothelial and follicular development, and if the endothelial thickness was <7 mm, the dosage of estradiol valerate was increased to 3-4 mg po bid as appropriate. The number of days of hormone replacement ranged from 11-20 days, and when the endothelial thickness was 7 mm, luteinizing hormone vaginal slow-release gel 90 mg pv qd was added, as well as dexedrine and progesterone 10 mg po bid to transform the endothelium 2 or 3 days later or 5 days later. Progesterone 10 mg po bid was added to transform the endothelium, and cleavage stage embryos were transferred 2 or 3 days later, or blastocysts were transferred 5 days later. Luteal support as described above was continued for a total of 14 days after transfer.

Outcomes

Primary Outcome Measures

Live birth
The number of deliveries resulting in at least one live birth

Secondary Outcome Measures

Clinical pregnancy
Clinical pregnancies diagnosed by ultrasonographic visualisation of gestational sacs, the number of clinical pregnancies expressed per 100 embryo transfer cycles
embryo implantation
Serum Human Chorionic Gonadotropin levels >10 IU/L, the number of gestational sacs observed divided by the number of embryos transferred

Full Information

First Posted
July 31, 2023
Last Updated
August 16, 2023
Sponsor
International Peace Maternity and Child Health Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT06006091
Brief Title
The Effectiveness of the Letrozole-induced Endometrial Preparation Protocol in Frozen-thawed Embryo Transfer (FET)
Official Title
Clinical Outcomes of Letrozole-induced Endometrial Preparation Regimens Versus Conventional Endometrial Preparation Regimens Including Natural Cycle, Hormone Replacement Regimens in FET, a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
August 1, 2026 (Anticipated)
Study Completion Date
August 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
International Peace Maternity and Child Health Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this single center, non-blinded, randomized controlled clinical trial to comparison of pregnancy outcomes and perinatal outcomes in patients undergoing IVF treatment (including ICSI) with FET with letrozole-induce endothelial preparation protocol versus natural cycles, hormone replacement protocol. The main questions it aims to answer are: To investigate whether letrozole-induce endothelial preparation is effective in improving the live birth rate and clinical pregnancy rate. To explore its possible impact on clinically important indicators such as spontaneous abortion rate, implantation cycle cancellation rate, days of endothelial preparation, and number of visits to the clinic. The study subjects were randomized into groups starting at D1-D3 of the menstrual cycle. The study subjects were stratified according to whether their menstrual cycles were regular or not, and were divided into the following endothelial preparation regimens according to the pre-prepared stratified zoned randomized group numbers: (1) regular menstrual cycles (25-35 d): letrozole ovulation-promoting cycles, natural cycles, and hormone-replacement cycles; and (2) irregular menstrual cycles (<25 d or >35 d): letrozole ovulation-promoting cycles, hormone-replacement cycle.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Letrozole, Infertility, Female
Keywords
Frozen-thawed embryo transfer, Letroziole, Endothelial preparation protocol

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
858 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Letrozole-induced endometrial preparation protocol
Arm Type
Experimental
Arm Description
Starting at D3 of the menstrual cycle, letrozole 2.5 mg po qd was administered for 5 days. After 1 week, ultrasound was performed to dynamically monitor follicular development, and 75-150 IU im qd of human menopausal gonadotrophin (hMG) given to continue ovulation stimulation as needed, and oestradiol valerate 2 mg po qd was given to regulate endometrial thickness until the follicle developed to 16 mm in diameter and 7 mm in endometrial thickness. The follicles developed to ≥16 mm in diameter and ≥7 mm in lining thickness and were dynamically monitored by ultrasound and serum sex hormone levels to determine the day of ovulation. From the day of ovulation, dexamethasone 10 mg po tid was administered, and cleavage-stage embryos were transferred 2 or 3 days later, or blastocysts were transferred 5 days later. Deferiprone 10 mg po tid was continued for 14 days after transfer.
Arm Title
Natural cycles endometrial preparation protocol
Arm Type
No Intervention
Arm Description
Follicular development was monitored dynamically by ultrasound from D8-D11of the menstrual cycle until the follicles developed to ≥16 mm in diameter and ≥7 mm in endothelial thickness, and the day of ovulation was determined by dynamic ultrasound monitoring and detection of serum sex hormone levels. Deferiprone 10 mg po tid was administered from the day of ovulation, and D2 or D3 cleavage stage embryos were transferred 2 or 3 days later, or blastocysts were transferred 5 days later. Deferiprone 10 mg po tid was continued for a total of 14 days after transfer. Cycles were canceled if endothelial thickness was <7 mm on the day of ovulation or if serum progesterone levels were 5 nmol/L before ovulation.
Arm Title
Hormone replacement cycles endometrial preparation protocol
Arm Type
No Intervention
Arm Description
Starting from D1-D5 of the menstrual cycle, estradiol valerate 2 mg po bid was administered for 7 days, followed by ultrasound for dynamic monitoring of endothelial and follicular development, and if the endothelial thickness was <7 mm, the dosage of estradiol valerate was increased to 3-4 mg po bid as appropriate. The number of days of hormone replacement ranged from 11-20 days, and when the endothelial thickness was 7 mm, luteinizing hormone vaginal slow-release gel 90 mg pv qd was added, as well as dexedrine and progesterone 10 mg po bid to transform the endothelium 2 or 3 days later or 5 days later. Progesterone 10 mg po bid was added to transform the endothelium, and cleavage stage embryos were transferred 2 or 3 days later, or blastocysts were transferred 5 days later. Luteal support as described above was continued for a total of 14 days after transfer.
Intervention Type
Drug
Intervention Name(s)
Letrozole
Intervention Description
Different endothelial preparations according to groups, see arm descriptions for details
Primary Outcome Measure Information:
Title
Live birth
Description
The number of deliveries resulting in at least one live birth
Time Frame
40-42 weeks'estimated gestational age
Secondary Outcome Measure Information:
Title
Clinical pregnancy
Description
Clinical pregnancies diagnosed by ultrasonographic visualisation of gestational sacs, the number of clinical pregnancies expressed per 100 embryo transfer cycles
Time Frame
5-7 weeks' estimated gestational age
Title
embryo implantation
Description
Serum Human Chorionic Gonadotropin levels >10 IU/L, the number of gestational sacs observed divided by the number of embryos transferred
Time Frame
14 day after embryo transfer

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
As this was an assisted reproduction-related study, the population included was physiologically (with uterus and ovaries) and genetically (with XX sex chromosomes) female.
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women <40 years of age undergoing IVF or ICSI at our reproductive center with a total of ≤3 superovulation cycles , and with ≥2 cleavage embryos or ≥1 blastocyst were cryopreserved. Previous cycles of embryo transfer ≤ 2 and only one transfer cycle with 1-2 embryos per study subject was enrolled. Exclusion Criteria: Patients with chromosomal abnormalities in either spouse, hydrosalpinx, severe endometriosis, adenomyosis, and uterine and uterine cavity organic diseases such as uterine malformations, endometrial polyps, and uterine adhesions; patients who underwent pre-implantation genetic diagnosis (PGT); patients who underwent ICSI using surgically obtained epididymal or testicular spermatozoa; patients with a Body mass index (BMI, = weight/height2 ) > 30 kg/m2; patients with recurrent spontaneous abortions; patients with sequential embryo transfer.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chengliang Zhou, Dr.
Phone
08613758240793
Email
chengliang_zhou@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaojun Chen, Dr.
Phone
19921917097
Email
cxj8012@hotmail.com
Facility Information:
Facility Name
Yu Xiao
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Xiao, Dr.
Email
ethanhsiao@126.com

12. IPD Sharing Statement

Learn more about this trial

The Effectiveness of the Letrozole-induced Endometrial Preparation Protocol in Frozen-thawed Embryo Transfer (FET)

We'll reach out to this number within 24 hrs