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Effect of Timing Progesterone Luteal Support on Embryo Transfer

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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

Tracking Information
First Submitted Date  ICMJE January 30, 2017
First Posted Date  ICMJE February 2, 2017
Last Update Posted Date February 2, 2017
Actual Study Start Date  ICMJE November 1, 2015
Actual Primary Completion Date October 30, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2017)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Timing Progesterone Luteal Support on Embryo Transfer
Official Title  ICMJE Does the Time of Starting Progesterone (P4) Luteal Support (LS) Affects Embryo Transfer (ET) in Long Agonist Protocol Down-regulated ICSI Cycles?
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE
  • Progesterone Luteal Support in ICSI
  • Embryo Transfer
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Progesterone 100 IM/day
  • 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.
    Intervention: Drug: Progesterone 100 IM/day
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 1, 2017)
150
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 1, 2017
Actual Primary Completion Date October 30, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: infertile females undergoing first ICSI cycle
Ages  ICMJE 18 Years to 38 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03040830
Other Study ID Numbers  ICMJE P4 luteal support and ET
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mohamad Elsaid Ghanem, Mansoura Integrated Fertility Center
Study Sponsor  ICMJE Mansoura Integrated Fertility Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Mansoura Integrated Fertility Center
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP