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OpenTrials
Completed

NCT Number: NCT03040830

Effect of Timing Progesterone Luteal Support on Embryo Transfer

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

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Key information

Conditions

Progesterone Luteal Support in ICSI Embryo Transfer

Age range

18 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Progesterone 100 IM/day

Drug

Progesterone IM 100 mg /day was started on day of egg retrieval in egg retrieval arm and on day of embryo transfer in the embryo transfer arm

Primary outcomes

  1. difficult embryo transfer

    Time frame: 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 outcomes

  1. cycle outcome

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mansoura Integrated Fertility Center

Other

Registry information

Official study title

Does the Time of Starting Progesterone (P4) Luteal Support (LS) Affects Embryo Transfer (ET) in Long Agonist Protocol Down-regulated ICSI Cycles?

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Feb 2, 2017
Registry last updated
Feb 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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