Role of Indomethacin in Difficult Embryo Transfer.

Difficult Embryo Transfer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02642601
• Other study ID #: MS62014
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: December 24, 2015
• Last updated: December 24, 2015
• Start date: March 2014
• Est. completion date: January 2016

Study information

• Verified date: December 2015
• Source: Cairo University
• Contact: Mona M Shaban, MD
• Phone: +201001078586
• Email: drmonashaban[@]gmail.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 38 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Difficult Embryo Transfer

Intervention

Drug:
• Indomethacin(KAHIRA PHARMA&CHEM,IND,CO.CAIRO-EGYPT)
one dose of indomethacin 100 mg rectal suppository 1- 2 hours before embryo transfer

Locations

Country	Name	City	State
Egypt	IVF center,Cairo university hospital,Egypt	Cairo
Egypt	Kamal Shoeir private IVF center,Cairo,Egypt	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ongoing pregnancy rate	pregnancy exceeding 12 weeks gestation	after 12 weeks gestation	Yes
Primary	clinical pregnancy rate	+ve pregnancy test+ gestational sac with fetal pulsation by ultrasound	2 weeks after +ve pregnancy test	Yes
Secondary	Implantation rate	2-4 weeks after positive pregnancy test	the number of total gestational sacs divided by the total number of embryos transferred.	Yes