Effect of Timing Progesterone Luteal Support on Embryo Transfer

NCT03040830 | Completed Phase 4

• 1 other identifier: P4 luteal support and ET
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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

Conditions

Progesterone Luteal Support in ICSI; Embryo Transfer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• cycle outcome

  4 weeks

Study Arms (2)

Egg retrieval arm

EXPERIMENTAL

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

Embryo transfer arm

ACTIVE COMPARATOR

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

Interventions

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

Egg retrieval arm; Embryo transfer arm

Eligibility Criteria

• Age: 18 Years - 38 Years
• Gender Eligibility Details: infertile females undergoing first ICSI cycle
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• first ICSI trial, normal uterus, normal cervix, normal ovarian response ,easy mock transfer,patient consenting

You may not qualify if:

• age over 38, difficult mock transfer, low and high ovarian response, patient not consenting

Sponsors & Collaborators

• Mansoura Integrated Fertility Center: lead

Related Publications (4)

• 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. doi: 10.1093/humrep/dei437. Epub 2005 Dec 22.

  PMID: 16373409 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• Ghanem ME, Bedairy MH, Shaaban A, Albahlol IA. Does the Time of Starting Progesterone Luteal Support Affect Embryo Transfer in Long Agonist Protocol Downregulated ICSI Cycles? A Randomized Controlled Trial. Reprod Sci. 2021 Mar;28(3):897-903. doi: 10.1007/s43032-020-00309-0. Epub 2020 Sep 9.

  PMID: 32909190 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The randomization
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: January 30, 2017
• First Posted: February 2, 2017
• Study Start: November 1, 2015
• Primary Completion: October 30, 2016
• Study Completion: January 1, 2017
• Last Updated: February 2, 2017

Record last verified: 2017-01