NCT05189145

Hormonal Monitoring and Progesterone Adjustment in Frozen Embryo Transfer Cycles

A Prospective Randomized Study of the Impact of Hormonal Monitoring and Progesterone Supplementation Adjustment on Outcome of Programmed Thawed Embryo Transfer Cycles

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: Alexandria University · Academic / Other
• Sex: Female
• Age: 20 Years – 42 Years
• Healthy volunteers: Not accepted

Summary

Hormonal monitoring impact on overall pregnancy rate in frozen embryo transfer (FET)cycles and hence progesterone supplement adjustments remain debatable in current literature. This prospective randomized study aims to investigate the effect of monitoring and follow-up of serum progesterone, estradiol \& luteinizing hormone (LH) levels and progesterone supplement adjustments on pregnancy outcomes for FET in programmed hormonal replacement therapy cycles in comparison with ultrasound only in control group

Detailed description

Progesterone (P4) is a steroidal hormone that is required for successful embryo implantation and maintenance of the pregnancy in natural cycles, fresh in vitro fertilization cycles, and frozen embryo transfer (FET) cycles. Women undergoing FET in programmed cycle are unable to provide adequate endogenous P4 and require progesterone supplementation to initiate and maintain the secretory endometrium and pregnancy. There has been previous research into luteal phase support in frozen cycles, which has demonstrated that supplementation of progesterone does impact outcome in FET. Despite this evidence for the role of progesterone, there is surprisingly little data on the optimal values for serum P4 during the luteal phase and specifically on the day of embryo transfer in frozen cycles. Following years of a prevalent belief that the higher values of P4 are better, it seems that there may be an optimal window for P4 values during the luteal phase in bovine IVF. Though progesterone levels on the day of transfer have not yet been studied extensively in humans, tailoring the time of transferring a frozen embryo based on serial P4 values rather than cycle day number alone results in higher pregnancy rates. By direct action on the endometrium, a rise of LH might interfere with endometrial receptivity during a FET cycle, in which no pituitary suppression is used. The significance of LH level on the day before addition of progesterone is not yet well defined. The aim of this study is to investigate the effect of monitoring and follow-up of serum progesterone, estradiol \& luteinizing hormone levels on day of embryo transfer on pregnancy outcomes for FET in programmed HRT cycles in comparison with ultrasound only in control group and to evaluate the effect of progesterone supplements adjustments depending on serum progesterone levels on day of FET in affecting clinical pregnancy rate.

Conditions

• Female Infertility

Interventions

Type	Name	Description
DRUG	estradiol valerate	8mg orally on daily basis for 13 days beginning with the first day of either a spontaneously or induced menstrual cycle then assess by ultrasound
OTHER	Hormonal monitoring progesterone, estradiol, luteinizing hormone	Serum Progesterone, estrogen \& LH measured on day 13 after priming endometrium with 8mg estradiol valerate on a daily basis beginning as early as the first day of menstrual cycle.
DIAGNOSTIC_TEST	transvaginal ultrasound examination	Patients examined using transvaginal ultrasonography on day 13 of exogenous estrogen supplementation to measure endometrial thickness and to detect signs of escape ovulation
DRUG	Progesterone 400 Mg Vaginal Suppository	Progesterone supplements given in form of daily two vaginal prontogest suppositories400 mg each
OTHER	Hormonal monitoring progesterone and estradiol	Measuring the serum Progesterone \& Estradiol in the early morning on the day of embryo transfer an progesterone supplementation adjusted as follows: Group II A: If P4 levels \< 5ng/dl, one 100 mg intramuscular injection daily added, Group II B: If P4 levels 5-10ng/dl, dydrogesterone three times daily added. Group II C: If P4 levels \>10ng, continued on 400 mg prontogest suppositories twice daily
DRUG	Progesterone	group II A: 100 mg intramuscular injection daily Group II B: If P4 levels 5-10ng/dl dydrogesterone added

Timeline

• Start date: 2019-10-01
• Primary completion: 2021-03-15
• Completion: 2021-10-01
• First posted: 2022-01-12
• Last updated: 2024-02-02

Locations

1 site across 1 country: Egypt