NCT03105323

Brief Summary

This study will be conducted at the In vitro fertilization Unit at Ain Shams University Maternity Hospital. Women will be recruited from the In vitro fertilization Unit who will fulfill the inclusion criteria. They will be counseled to be included into the study The study will assess Role of Ratio of Progesterone to Number of Follicles as a Prognostic Tool for Intracytoplasmic Sperm Injection outcome.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2017

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 7, 2017

Completed
24 days until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
Last Updated

April 7, 2017

Status Verified

April 1, 2017

Enrollment Period

11 months

First QC Date

March 24, 2017

Last Update Submit

April 6, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • clinical pregnancy rate

    rate of incidence of pregnancy after Intracytoplasmic Sperm Injection

    a year

Study Arms (1)

infertile women

All patients were pretreated with Gonadotropin releasing hormone agonist (decapeptyl®) 0.05 mg/day from 10 days prior to the start of menstruation. The patients'ovaries were stimulated with a recombinant follicle-stimulating hormone (FSH, subcutaneous) from day 2 of the menstrual cycle. human chorionic gonadotropin was administered when at least two follicles vary 18-22mm were observed on ultrasonography.Blood samples were collected on the day of final Human chorionic gonadotropin maturation, and serum P levels were measured.Pregnancy was defined by titers within 11 days following Embryo transfer,Clinical pregnancy was defined by the observation of intrauterine embryo heart motion by 7 weeks gestation.

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

This study will be conducted at the IVF Unit at Ain Shams University Maternity Hospital. Women will be recruited from the IVF Unit who will fulfill the inclusion criteria. They will be counseled to be included into the study.

You may qualify if:

  • Women with any type of subfertility undergoing IVF treatment.
  • Age between (20-40) years old
  • Body mass index between (20-40)
  • Selected embryo are of grade 1 and 2 quality.

You may not qualify if:

  • Age above 40 years old
  • BMI above 40
  • Bad quality embryo
  • Uterine anomalies or malformation that affect embryo transfer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Central Study Contacts

Mohamed Daoud

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of Obstetrics and gynecology

Study Record Dates

First Submitted

March 24, 2017

First Posted

April 7, 2017

Study Start

May 1, 2017

Primary Completion

March 31, 2018

Study Completion

March 31, 2018

Last Updated

April 7, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share