Serum Progesterone Level in HRT-FET：a RCT

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

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.

Study Overview

• Status: Unknown
• Conditions: Progesterone,Hormone Replacement Thawed Embryo Transfer Cycles
• Intervention / Treatment: Drug: intramuscular progesterone 20-40mg from D3 until pregnancy test

• Study Type: Interventional
• Enrollment (Anticipated): 423
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A1; The included patient should test serum progesterone level on D3 no matter which day perform the embryo transfer. According to the progesterone level, there are two groups, Group A: serum progesterone <7.24ug/L, followed by randomized A1: plus additional treatment（intramuscular progesterone 20-40mg from D3 ）	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 ）
No Intervention: A2; The included patient should test serum progesterone level on D3 no matter which day perform the embryo transfer. According to the progesterone level, there are two groups, Group A: serum progesterone <7.24ug/L, followed by randomized A2：without additional treatment
No Intervention: B; Group B：serum progesterone ≥7.24ug/L， without additional treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ongoing pregnancy rate	beyond pregnancy week 12 in HRT-FET cycles	10 weeks after embryo transfer

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical pregnancy rate	intrauterine gestational sacs by ultrasound	10 weeks after embryo transfer

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Publications and helpful links

General Publications

• Haiyan L, Gang Y, Yu L, Lin L, Xiaoli C, Qingxue Z. Does serum progesterone level impact the ongoing pregnancy rate in frozen embryo transfer under artificial preparation with vaginal progesterone? Study protocol for a randomized controlled trial. Trials. 2022 Jan 3;23(1):3. doi: 10.1186/s13063-021-05953-8.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2020
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): April 1, 2021

Study Registration Dates

• First Submitted: January 27, 2020
• First Submitted That Met QC Criteria: January 28, 2020
• First Posted (Actual): January 30, 2020

Study Record Updates

• Last Update Posted (Actual): January 30, 2020
• Last Update Submitted That Met QC Criteria: January 28, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Progesterone
• Other Study ID Numbers: 2019-HRT-P-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No