Timing and Intrauterine Insemination in Unexplained Infertility

NCT03920514 | Unknown Phase 4

• 1 other identifier: Intrauterine insemination
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

to determine the most suitable time for administration of (human chorionic gonadotropin )hCG prior to intrauterine insemination (IUI) to optimize pregnancy outcome and to have the best success rates so the cases divided in to four groups according to the time of hCG administration .

Conditions

Intrauterine Insemination

Keywords

infertility

Outcome Measures

Primary Outcomes (2)

• Primary outcome

  Positive serum beta hCG test

  14 days after IUI

• Secondary outcome

  Clinical pregnancy defined as prescence of at least one Intrauterine gestational sac with fetal pole on Transvaginal scan

  4 weeks after insemination

Study Arms (4)

GROUP 1

ACTIVE COMPARATOR

IUI 24 hours after hCGadminstration

Drug: hCG

GROUP 2

ACTIVE COMPARATOR

IUI 36 hours after hCG adminstration

Drug: hCG

GROUP 3

ACTIVE COMPARATOR

IUI 48 hours after hCG adminstration

Drug: hCG

GROUP 4

ACTIVE COMPARATOR

IUI at time of hCG adminstration

Drug: hCG

Interventions

hCG DRUG

Women will be given hCG before or with IUI

Also known as: Pregnyl

GROUP 1; GROUP 2; GROUP 3; GROUP 4

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Mild male infertility or unexplained infertility

You may not qualify if:

• Adanced male factor endometriosis uterine abnormality sever semen parameters i impairment according to WHO 2010 non ovulatory cycles bilatral tubal block

Sponsors & Collaborators

• Sohag University: lead

Related Publications (3)

• Aydin Y, Hassa H, Oge T, Tokgoz VY. A randomized study of simultaneous hCG administration with intrauterine insemination in stimulated cycles. Eur J Obstet Gynecol Reprod Biol. 2013 Oct;170(2):444-8. doi: 10.1016/j.ejogrb.2013.07.022. Epub 2013 Aug 6.

  PMID: 23932307 BACKGROUND

• Cantineau AE, Janssen MJ, Cohlen BJ, Allersma T. Synchronised approach for intrauterine insemination in subfertile couples. Cochrane Database Syst Rev. 2014 Dec 21;2014(12):CD006942. doi: 10.1002/14651858.CD006942.pub3.

  PMID: 25528596 BACKGROUND

• Yumusak OH, Kahyaoglu S, Pekcan MK, Isci E, Cinar M, Tasci Y. Does intrauterine insemination timing matter for achieving pregnancy during ovulation induction using gonadotropins? A retrospective cohort study. J Chin Med Assoc. 2017 Jun;80(6):366-370. doi: 10.1016/j.jcma.2016.06.005. Epub 2016 Sep 27.

  PMID: 27686502 BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

Chorionic Gonadotropin

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pregnancy Proteins; Proteins

Study Officials

• Allam Mohamed Abd elmonam, Professor of obs and gyn

  Faculty of medicine sohag university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Salwa Sabry Ahmed, Candidate

CONTACT

+201022616301; drsalwasabry@yahoo.com

Mohamed Sabry Ebrahim, Lecture of obs and gyn

CONTACT

+201096254975

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty of medicine sohag university

Model Details: Women will be randomly divided in to four groups the first Group will undergo IUI after 24 H of hCG administration the second g will undergo IUI after 36 h after hCG the third Group will undergo IUI after 48h of hCG administration the last Group will undergo IUI at the time of hCG adminstration

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 19, 2019
• Study Start: April 30, 2019
• Primary Completion: September 30, 2019
• Study Completion: December 31, 2019
• Last Updated: April 19, 2019

Record last verified: 2019-04