Effect of Timing Progesterone Luteal Support on Embryo Transfer
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ClinicalTrials.gov Identifier: NCT03040830 |
Recruitment Status :
Completed
First Posted : February 2, 2017
Last Update Posted : February 2, 2017
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Condition or disease | Intervention/treatment | Phase |
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Progesterone Luteal Support in ICSI Embryo Transfer | Drug: Progesterone 100 IM/day | Phase 4 |
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 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 |

Arm | Intervention/treatment |
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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.
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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.
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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 |
- 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
- 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.

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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 |
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 Key Record Dates |
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 |
Progesterone Progestins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |