Effect of Timing Progesterone Luteal Support on Embryo Transfer

• ClinicalTrials.gov Identifier: NCT03040830
• Recruitment Status: Completed
• First Posted: February 2, 2017
• Last Update Posted: February 2, 2017
• Sponsor: Mansoura Integrated Fertility Center
• Information provided by (Responsible Party): Mohamad Elsaid Ghanem, Mansoura Integrated Fertility Center

Study Description

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

• 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

Arms and Interventions

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

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

• 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

No Contacts or Locations Provided

More Information

Publications:

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. Epub 2005 Dec 22.

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):

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.

• 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
• Last Update Posted: February 2, 2017
• Last Verified: January 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Progesterone; Progestins; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs