MedDataX Logo

Effect of Vitamin D Status on Clinical Pregnancy Rates Following Intra Cytoplasmic Sperm Injection

NCT ID: NCT02987478

Last Updated: 2016-12-09

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

All patients will undergo in vitro fertilization.

Serum 25 (OH) D samples will be collected within1 week before oocyte retrieval.

Whole blood specimens will be collected in serum separator tubes using acceptable medical techniques to avoid hemolysis.

Ultrasound guided fresh embryo transfer will be performed on day 5 after fertilization.

clinical pregnancy will be confirmed by observation of intrauterine sac visible on ultrasound performed 4-5 weeks after embryo transfer.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

PATIENTS AND METHODS

Protocol Outline:

The Study:

Study site:

Ain Shams University Maternity Hospital.

Study Design:

A prospective Cohort study.

Study setting:

The study will be conducted at Ain Shams University Maternity Hospital.

Study population:

The study will include all women planned to undergo IVF due to unexplained infertility.

Methodology:

The study will be approved by the hospital ethics committee.

All included women will undergo the following:

* History taking.
* General and abdominal examination.
* Vaginal examination and assessment
* Pelvic ultrasound.
* Routine laboratory investigations including complete blood picture, hematocrit, liver and kidney function tests and coagulation profile.
* Preoperative senior anesthetist assessment.
* Hysteroscopy.

All patients will undergo IVF.

Serum 25(OH)D samples will be collected within1 week before oocyte retrieval.

Whole blood specimens will be collected in serum separator tubes using acceptable medical techniques to avoid hemolysis.

Ultrasound-guided fresh embryo transfer will be performed on day 5 after fertilization.

clinical pregnancy will be confirmed by observation of intrauterine sac visible on ultrasound performed 4-5 weeks after embryo transfer.

Measurement of Outcomes

1. serum 25 (OH) D levels.
2. Number of oocyte.

Most studies put the optimal number of retrieved oocytes between 10 and 15.
3. The implantation rate:

Calculated as the number of gestational sacs observed by ultrasound divided by the number of embryos transferred, multiplied by 100.
4. Number of gestational sac.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infertility

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Vitamin D following intra cytoplasmic sperm injection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age between 20 and 35 years old.
* Body mass index between 20 - 30.
* Unexplained infertility .
* Follicle-stimulating hormone level 12 IU/L or lower (baseline level, cycle day 3).
* Normal hysteroscopy ( healthy uterus with no fibroids or other growths)
* Fresh embryo transfer of 2 or more blastocysts stage.
* Embryo transfer on day 5 after fertilization

Exclusion Criteria

* Women younger than 20 years old or older than 35 years old.
* Previous one or more failed IVF.
* Uncorrected congenital or acquired uterine anomalies.
* Other causes of infertility rather than unexplained infertility.
* Less than 2 embryo transfer, cleavage stager frozen embryo transfer.
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ain Shams Maternity Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Alaa Sayed Abdul-hafeez

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ain Shams University Maternity Hospital

Cairo, Abbassia, Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mohammed Samy, MD

Role: CONTACT

Phone: +20100 194 7488

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Moh Samy, MD

Role: primary

Mohammed Samy, MD

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

6789

Identifier Type: -

Identifier Source: org_study_id