Clinical trial NCT03040830: Effect of Timing Progesterone Luteal Support on Embryo Transfer
Official title: Does the Time of Starting Progesterone (P4) Luteal Support (LS) Affects Embryo Transfer (ET) in Long Agonist Protocol Down-regulated ICSI Cycles?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Progesterone Luteal Support in ICSI
Embryo Transfer
Lead sponsor: Mansoura Integrated Fertility Center
Sponsor class: OTHER
First posted: 2017-02-02
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: difficult embryo transfer
timeFrame: 3 minutes
Secondary outcomes:
measure: cycle outcome
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
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
citation: 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
citation: 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.