Effect of Timing Progesterone Luteal Support on Embryo Transfer

February 1, 2017 updated by: Mohamad Elsaid Ghanem, Mansoura Integrated Fertility Center

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Egg retrieval arm
67 ICSI cases are started daily 100 mg IM prontogest on the day of egg retrieval until the day of pregnancy test.
Drug: Progesterone 100 IM/day
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
Active Comparator: Embryo transfer arm
66 ICSI cases are started daily 100 mg IM prontogest on the day of embryo transfer until the day of pregnancy test.
Drug: Progesterone 100 IM/day
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura Integrated Fertility Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Actual)

October 30, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

January 30, 2017

First Submitted That Met QC Criteria

February 1, 2017

First Posted (Estimate)

February 2, 2017

Study Record Updates

Last Update Posted (Estimate)

February 2, 2017

Last Update Submitted That Met QC Criteria

February 1, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P4 luteal support and ET

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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