Effect of Timing Progesterone Luteal Support on Embryo Transfer

Phase 4

Completed

• Conditions: Progesterone Luteal Support in ICSI; Embryo Transfer
• Interventions: Drug: Progesterone 100 IM/day

• Registration Number: NCT03040830
• Lead Sponsor: Mansoura Integrated Fertility Center

Brief Summary

The study aims to know whether starting progesterone luteal support in intra cytoplasmic sperm injection (ICSI) cycles on the day of ovum pickup affects the degree of difficulty of embryo transfer compared with starting luteal support on day of embryo transfer

Detailed Description

Double blind Randomized Controlled Trial (RCT) : the clinicians and the patents were blinded of the allocation group.

A total of 137 embryo transfers were randomly allocated into either arm I (67 ) starting luteal support as daily IM injections of 100 mg prontogest on day of egg retrieval , or arm II (66) starting the same P4 dose on day of embryo transfer

Study Timeline

• Study Start: 2015-11-01
• Primary Completion: 2016-10-30
• Status Verified: 2017-01
• Study Completion: 2017-01-01
• Study First Submitted: 2017-01-30
• Study First Submitted QC: 2017-02-01
• Last Update Submitted: 2017-02-01
• Study First Posted: 2017-02-02
• Last Update Posted: 2017-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• first ICSI trial, normal uterus, normal cervix, normal ovarian response ,easy mock transfer,patient consenting

Exclusion Criteria

• age over 38, difficult mock transfer, low and high ovarian response, patient not consenting

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Egg retrieval arm	Progesterone 100 IM/day	67 ICSI cases are started daily 100 mg IM prontogest on the day of egg retrieval until the day of pregnancy test.
Embryo transfer arm	Progesterone 100 IM/day	66 ICSI cases are started daily 100 mg IM prontogest on the day of embryo transfer until the day of pregnancy test.

Primary Outcome Measures

Name	Time	Method
difficult embryo transfer	3 minutes	presence of blood on embryo transfer catheter and or need for sounding or dilating the cervix to pass the embryo transfer catheter to the endometrial cavity

Secondary Outcome Measures

Name	Time	Method
cycle outcome	4 weeks	clinical cycle pregnancy rate calculated as number of clinical pregnancies (gestational sacs shown by ultrasound ) per 100 cases transferred multiplied by 100.Implantation rate calculated by the outcome of dividing the total number of gestational sacs in the arm by the total number of embryos transferred.