Effect of Timing Progesterone Luteal Support on Embryo Transfer

Embryo Transfer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03040830
• Other study ID #: P4 luteal support and ET
• Status: Completed
• Phase: Phase 4
• First received: January 30, 2017
• Last updated: February 1, 2017
• Start date: November 1, 2015
• Est. completion date: January 1, 2017

Study information

• Verified date: January 2017
• Source: Mansoura Integrated Fertility Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 1, 2017
• Est. primary completion date: October 30, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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

Related Conditions & MeSH terms

• Embryo Transfer
• Progesterone Luteal Support in ICSI

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura Integrated Fertility Center

References & Publications (3)

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

Mochtar MH, Van Wely M, Van der Veen F. Timing luteal phase support in GnRH agonist down-regulated IVF/embryo transfer cycles. Hum Reprod. 2006 Apr;21(4):905-8. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	difficult embryo transfer	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	cycle outcome	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