Serum Progesterone Level in HRT-FET：a RCT

Progesterone,Hormone Replacement Thawed Embryo Transfer Cycles Clinical Trial

Official title:

The Effect of Serum Progesterone Level on Day 3 in HRT-FET Cycles on the Clnical Outcome: a Randomized Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04248309
• Other study ID #: 2019-HRT-P-05
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2020
• Est. completion date: April 2021

Study information

• Verified date: January 2020
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In the window of implantation, progesterone plays an important role. Sufficient serum progesterone is basic for ongoing pregnancy. Vaginal progesterone is more and more widely used in ART. As it has no hepatic first pass effect. What is the optimal serum level for pregnancy when use vaginal progesterone is not known yet? Hormone replacement therapy- FET is the optimal strategy to explore this question. There are some retrospective studies showed that the serum progesterone level on embryo transfer day (D3 or D5) or pregnancy test day (D14) lower than 10-11ng/ml is significantly associated with ongoing pregnancy rate in HRT-FET cycles. This prospective study is designed to compare the ongoing pregnancy rate between different serum progesterone levels on D3 and to explore the intervention of additional progesterone supplement since D3 is helpful in HRT-FET cycles.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 423
• Est. completion date: April 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 41 Years

Eligibility

Inclusion Criteria:

1. HRT-FET cycles,including GnRHa-HRT-FET

2. Age<41 years old

3. BMI<30kg/m2

4. TSH and PRL normal

5. Endometrium thickness =8mm on D0 6) embryo transfer completed with at least 1 top-quality embryo (7-9 cell Grade 1 or D5 beyond grade 3 ) 7) Scandalized luteal phase support: transvaginal progesterone 0.2 tid with or without oral progesterone 10mg bid 8) included once for every patient

Exclusion Criteria:

1. history of Moderate and Severe uterine adhesion;

2. presence of hydrosapinx diameter >2cm

3. Endometrosis at stage III-IV

4. Recurrent implantation failure (>3 times of embryo transfer cycle)

Related Conditions & MeSH terms

• Progesterone,Hormone Replacement Thawed Embryo Transfer Cycles

Intervention

Drug:
• intramuscular progesterone 20-40mg from D3 until pregnancy test
serum progesterone <7.24ug/L, followed by randomized A1: plus additional treatment(intramuscular progesterone 20-40mg from D3 )

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ongoing pregnancy rate	beyond pregnancy week 12 in HRT-FET cycles	10 weeks after embryo transfer
Secondary	Clinical pregnancy rate	intrauterine gestational sacs by ultrasound	10 weeks after embryo transfer