Role of Indomethacin in Difficult Embryo Transfer.

Role of Indomethacin in Cases of Difficult Embryo Transfer in Intra Cytoplasmic Sperm Injection Cycles

the aim of the study is to assess the role of indomethacin in cases of difficult embryo transfer in intracytoplasmic sperm injection cycles.

Study Overview

• Status: Unknown
• Conditions: Difficult Embryo Transfer
• Intervention / Treatment: Drug: Indomethacin(KAHIRA PHARMA&CHEM,IND,CO.CAIRO-EGYPT)

Detailed Description

It is a prospective randomized study in which 200 women undergoing ICSI( intracytoplasmic sperm injection) and fulfilling the inclusion criteria(Difficult mock embryo transfer on day of ovum pick up ,Women's age 20-38 yaears,Early follicular FSH ≤10 IU/l ,Tubal, male infertility, unexplained factors of infertility.) will be recruited.

All patients will received long stimulation protocol ;down regulation will be achieved by administration of triptorelin0.1 mg(decapeptyl 0.1 mg, Ferring, Malmo, sweden) S.C daily from day 21 of the cycle preceding the stimulation cycle till the day of hCG administration.,down regulation will be checked day 2 of stimulation cycle by checking serum E2˂50 pg/ml, endometrial thickness ˂ 5mm and quiescent both ovaries.

When down regulation is achieved stimulation is commenced using hmG(Menogon, ferring pharmaceuticals, Germany) 225 IU daily intramuscular injection, Serial trans-vaginal ultrasound to assess follicular growth and serum E2 are done starting on day 6 of the cycle and onward, with adjustments of gonadotropin dose and monitoring frequency based on patient response.

Once 3 or more leading follicles reached≥18mm hCG 10000 IU (Pregnyl; NV Organon) will be administrated IM.

Ovum pick up will be done 34-36 hours following hCG administration with ultrasound guidance under general anesthesia.after that mock embryo transfer will be done using labotec embryo transfer catheter and women in which any degree of difficulty according to Tomas et al. 2002 criteria will be recruited in the study and divided randomly into two groups according to computer generated random cards ;group A (n=100): will receive indomethacin 100 mg rectal supp(KAHIRA PHARMA&CHEM,IND,CO.CAIRO-EGYPT) 1-2 hours before embryo transfer, group B (n=100) will not receive any medications before embryo transfer.

Embryo transfer of 2 embryos will be done by the same technique in lithotomy position with full bladder under ultrasound guidance 2-3 days after ovum pick up depending on the number and quality of available embryos using labotec catheter (Labotec, Gottingen Germanny).

Luteal phase will be achieved Using progesterone vaginal pessaries (Cyclogest, Alpharma, UK) 400 mg twice daily from the day of egg collection till the day of the pregnancy test and continued till 12 week gestation if pregnancy is documented.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • IVF center,Cairo university hospital,Egypt
    • Contact: Mona M Shaban, MD; Phone Number: +201001078586; Email: drmonashaban@gmail.com
    • Contact: Sherin H Gad Allah, MD; Phone Number: +201097665573; Email: sherinehosny@gmail.com
  • Cairo, Egypt
    • Recruiting
    • Kamal Shoeir private IVF center,Cairo,Egypt
    • Contact: Mona M Shaban, MD; Phone Number: +201001078586; Email: drmonashaban@gmail.com
    • Contact: Sherine H Gad Allah, MD; Phone Number: +201097665573; Email: sherinehosny@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Infertile patients undergoing ICSI cycle with difficult mock transfer done on day of day of ovum pick up

Exclusion Criteria:

• repeated ICSI failure
• Easy mock embryo transfer on day of ovum pick up
• Early follicular FSH >10 IU/l
• Past history of allergy to NSAID.
• Past history of asthma, peptic ulcer disease or inflammatory bowel disease. Endometrial pathology

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: indomethacin; one dose of indomethacin 100 mg rectal suppository;will be adminstrated1-2 hours before embryo transfer	Drug: Indomethacin(KAHIRA PHARMA&CHEM,IND,CO.CAIRO-EGYPT); one dose of indomethacin 100 mg rectal suppository 1- 2 hours before embryo transfer; Other Names: indocid
No Intervention: no medication; no indomethacine before embryo transfer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical pregnancy rate	+ve pregnancy test+ gestational sac with fetal pulsation by ultrasound	2 weeks after +ve pregnancy test

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implantation rate	2-4 weeks after positive pregnancy test	the number of total gestational sacs divided by the total number of embryos transferred.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
ongoing pregnancy rate	pregnancy exceeding 12 weeks gestation	after 12 weeks gestation

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Mona M Shaban, MD, Cairo university

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): January 1, 2016

Study Registration Dates

• First Submitted: December 24, 2015
• First Submitted That Met QC Criteria: December 24, 2015
• First Posted (Estimate): December 30, 2015

Study Record Updates

• Last Update Posted (Estimate): December 30, 2015
• Last Update Submitted That Met QC Criteria: December 24, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: indomethacin, ICSI, difficult embryo transfer
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Reproductive Control Agents; Gout Suppressants; Tocolytic Agents; Indomethacin
• Other Study ID Numbers: MS62014