Timing and Intrauterine Insemination in Unexplained Infertility

NCT ID: NCT03920514

Last Updated: 2019-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-30

Study Completion Date

2019-12-31

Brief Summary

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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 .

Detailed Description

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IUI with or without ovarian stimulation is a common treatment for infertility ,it is a simple procedure the semen is prepared in the laboratory and transferred by a catheter and injected intrauterine .ultrasound folliculometry is used for monitoring follicular growth where some clinicians prefer the natural cycles and others prefer ovarian stimulation and human chorionic gonadotropin (hCG)trigger for better timing .so cases will take induction and folliculometry will be done until the follicle reach 18mm trigger with hCG .women will be randomly divided to four groups .the first group will undergo IUI at 24 after trigger the second IUI at36 hour after trigger the thirdG at 48 after trigger and finaly the last group IUI will be done simultaneos with trigger the out come the number of pregnant women for each group.

Conditions

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Intrauterine Insemination

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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GROUP 1

IUI 24 hours after hCGadminstration

Group Type ACTIVE_COMPARATOR

hCG

Intervention Type DRUG

Women will be given hCG before or with IUI

GROUP 2

IUI 36 hours after hCG adminstration

Group Type ACTIVE_COMPARATOR

hCG

Intervention Type DRUG

Women will be given hCG before or with IUI

GROUP 3

IUI 48 hours after hCG adminstration

Group Type ACTIVE_COMPARATOR

hCG

Intervention Type DRUG

Women will be given hCG before or with IUI

GROUP 4

IUI at time of hCG adminstration

Group Type ACTIVE_COMPARATOR

hCG

Intervention Type DRUG

Women will be given hCG before or with IUI

Interventions

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hCG

Women will be given hCG before or with IUI

Intervention Type DRUG

Other Intervention Names

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Pregnyl

Eligibility Criteria

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Inclusion Criteria

* Mild male infertility or unexplained infertility

Exclusion Criteria

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

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Salwa Sabry Ahmed Mohamed

Faculty of medicine sohag university

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Allam Mohamed Abd elmonam, Professor of obs and gyn

Role: PRINCIPAL_INVESTIGATOR

Faculty of medicine sohag university

Central Contacts

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Salwa Sabry Ahmed, Candidate

Role: CONTACT

+201022616301

Mohamed Sabry Ebrahim, Lecture of obs and gyn

Role: CONTACT

+201096254975

References

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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.

Reference Type BACKGROUND
PMID: 23932307 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25528596 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27686502 (View on PubMed)

Other Identifiers

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Intrauterine insemination

Identifier Type: -

Identifier Source: org_study_id

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