Effect of Timing Progesterone Luteal Support on Embryo Transfer

Study Overview
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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

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

Conditions
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Progesterone Luteal Support in ICSI, Embryo Transfer

Intervention / Treatment
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* Drug: Progesterone 100 IM/day


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Egg retrieval arm<br>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<br>* 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<br>|
| Active Comparator: Embryo transfer arm<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |