Effects of Pentoxifylline and Vitamin E on Pregnancy Rate in Infertile Women Treated by ICSI:

NCT03476564 | Unknown Early Phase 1

• 1 other identifier: BenhaU1
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Our findings will provide preliminary clinical evidence to suggest the new experimental treatment approaches, toward female factor infertility treatment with pentoxyfylline.

Conditions

Infertility, Female

Keywords

assisted reproductive techniques

Outcome Measures

Primary Outcomes (2)

• clinical pregnancy rate.

  serum beta-hCG analysis 14 days after embryo transfer

  two weeks after embryo transfer

• clinical pregnancy rate

  transvaginal ultrasound scan will be scheduled 2 weeks after embryo transfer to confirm the diagnosis of clinical pregnancy

  two weeks after embryo transfer

Study Arms (2)

intervention group

EXPERIMENTAL

intervention group will receive pentoxifylline (Trental S.R.) 400 mg/BD plus vit E (PHARCO) 400 mg/BD 2 cycles before starting ICSI cycle and the medication will be continued until the beta-hCG becomes positive or the cycle is cancelled.

Drug: pentoxifylline; Drug: Vit E

comparison group

NO INTERVENTION

. The comparison group will not receive the above drugs. The main outcome measure will be clinical pregnancy rate.

Interventions

pentoxifylline DRUG

will be given 2 cycles before starting ICSI cycle and the medication will be continued until the beta-hCG becomes positive or the cycle is cancelled

Also known as: Trental S.R. 400 mg/BD

intervention group

Vit E DRUG

will be given 2 cycles before starting ICSI cycle and the medication will be continued until the beta-hCG becomes positive or the cycle is cancelled

Also known as: Vit E PHARCO 400 mg/BD

intervention group

Eligibility Criteria

• Age: 20 Years - 39 Years
• Gender Eligibility Details: female patients according to physical appearance and sex accepted socially
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• infertile female patients under 39 years

You may not qualify if:

• hypothalamic amenorrhea
• drug reactions or complications
• endometrioses
• fibroids

Sponsors & Collaborators

• Benha University: lead
• El Galaa Teaching Hospital: collaborator

Study Sites (1)

El Galaa Teaching hosptial

Cairo, Ghamra, Egypt

Location

MeSH Terms

Conditions

Infertility, Female

Interventions

Pentoxifylline

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

ahmed amr fayez, M.B.B.CH

CONTACT

(002)01066653186; ahmed_fayez275@yahoo.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Computer generated random number table will be used for randomization. Group assignments will be placed in sealed opaque sequentially numbered envelopes
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Model Details: Endometrial thickness will be measured on the day of the HCG prescription in both groups by one of the two attending physicians. Chemical pregnancy will be detected by serum beta-hCG analysis 14 days after embryo transfer and transvaginal ultrasound scan will be scheduled 2 weeks later to confirm the diagnosis of clinical pregnancy. The intervention group will receive pentoxifylline (Trental S.R.) 400 mg/BD plus vit E (PHARCO) 400 mg/BD 2 cycles before starting ICSI cycle and the medication will be continued until the beta-hCG becomes positive or the cycle is cancelled. The comparison group will not receive the above drugs. The main outcome measure will be clinical pregnancy rate.

Study Record Dates

• First Submitted: March 2, 2018
• First Posted: March 26, 2018
• Study Start: May 1, 2018
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: March 26, 2018

Record last verified: 2018-03

Locations

EG (1)