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Effect of Timing Progesterone Luteal Support on Embryo Transfer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03040830
Recruitment Status : Completed
First Posted : February 2, 2017
Last Update Posted : February 2, 2017
Sponsor:
Information provided by (Responsible Party):
Mohamad Elsaid Ghanem, Mansoura Integrated Fertility Center

Study Description
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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

Condition or disease Intervention/treatment Phase
Progesterone Luteal Support in ICSI Embryo Transfer Drug: Progesterone 100 IM/day Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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

A total of 137 embryo transfers (ETs) were randomly allocated into either group A (67 ) starting luteal support as daily intra muscular (IM) injections of 100 mg prontogest on day of egg retrieval, or group B (66) starting the same P4 dose on day of embryo transfer.Transfer technique was blind tactile using Labotect catheter and was considered difficult if the inner ET catheter was blood stained and /or sounding or dilating the cervix was needed. Cervical traction or blood staining of outer sheath did not indicate difficulty
Masking: Double (Participant, Care Provider)
Masking Description: The randomization
Primary Purpose: Treatment
Official Title: Does the Time of Starting Progesterone (P4) Luteal Support (LS) Affects Embryo Transfer (ET) in Long Agonist Protocol Down-regulated ICSI Cycles?
Actual Study Start Date : November 1, 2015
Actual Primary Completion Date : October 30, 2016
Actual Study Completion Date : January 1, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   infertile females undergoing first ICSI cycle
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:
Senciboy D.N and Sharpe-Timms K.L: Progesterone affects the cervix prior to embryo transfer. , Fertility and Sterility ,2001: 76 , Issue 3 , S220 - S221
Ghanem ME, Ragab AE, Alboghdady LA, Helal AS, Bedairy MH, Bahlol IA, Abdelaziz A. Difficult embryo transfer (ET) components and cycle outcome. Which is more harmful?. Middle East Fertility Society Journal. 2016 Jun 30;21(2):114-119

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mohamad Elsaid Ghanem, Professor, Mansoura Integrated Fertility Center
ClinicalTrials.gov Identifier: NCT03040830    
Other Study ID Numbers: P4 luteal support and ET
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: January 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs