Effect of Timing Progesterone Luteal Support on Embryo Transfer

NCT ID: NCT03040830

Last Updated: 2017-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-01

Study Completion Date

2017-01-01

Brief Summary

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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

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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

Conditions

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Progesterone Luteal Support in ICSI Embryo Transfer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
The randomization

Study Groups

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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.

Group Type EXPERIMENTAL

Progesterone 100 IM/day

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Progesterone 100 IM/day

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mansoura Integrated Fertility Center

OTHER

Sponsor Role lead

Responsible Party

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Mohamad Elsaid Ghanem

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type BACKGROUND
PMID: 16373409 (View on PubMed)

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

Reference Type 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

Reference Type 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.

Reference Type DERIVED
PMID: 32909190 (View on PubMed)

Other Identifiers

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P4 luteal support and ET

Identifier Type: -

Identifier Source: org_study_id

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