Vitamin D as a Prognostic Marker on Assisted Reproductive Technologies Outcomes.

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

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2023-11-30

Brief Summary

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Studying the effect of Vitamin D administration on assisted reproductive outcomes in women undergoing Intra Cytoplasmic Sperm Injection (ICSI) by giving a dose of vitamin D and determining the effect of this dose on both the quality embryos, implantation and ongoing pregnancy rate.

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Detailed Description

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1. Ninty women will include in the study. All patients will be treated with gonadotropin releasing hormone (GnRH) agonist "Decapeptyl" 0.1 mg subcutenoussubcutaneous "FeringFerring, Germany" and vitamin D (D- Dep) from day 20 of the preceding cycle till the day of HCG administration for preparation of ICSI.
2. Controlled ovarian hyper stimulation will be done with Gonal F "recombinant FSH", starting from day 3 of the stimulation cycle according to the standard protocol of the center. The dose is calculated according to the ovarian reserve, age as the BMI.
3. HCG and Vitamin D will be given when one or more of the growing follicles reaching 17 mm of diameter or more.
4. Ovum pickup was done guided by the transvaginal ultrasonography 34-36 hours after HCG administration. Follicular fluid and blood sample were obtained at the time of ovum pickup for ICSI/IVF.
5. This prospective randomized case control trial will include 90 women who will be allocated IVF/ICSI. They will be sub divided into a study and a control group; each group will include 45 women.

Conditions

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Role of Vitamin D in IVF for Better Outcome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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control

Control group in which vitamin D was not administrated.

Group Type SHAM_COMPARATOR

Vitamin D

Intervention Type DRUG

To investigate role of vitamin D in follicular maturation and number of mature follicles which help in the success of IVF procedure

Study group

Study group in which Vitamin D was administered

Group Type ACTIVE_COMPARATOR

Vitamin D

Intervention Type DRUG

To investigate role of vitamin D in follicular maturation and number of mature follicles which help in the success of IVF procedure

Interventions

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Vitamin D

To investigate role of vitamin D in follicular maturation and number of mature follicles which help in the success of IVF procedure

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age is between 20-40 years old.
2. Non PCOS patient.
3. With no previous or current evidence of OHSS (number of oocyte between 5-15 oocytes)
4. Normal Prolactin level.
5. No other endocrinological abnormality including thyroid disorder or diabetes.
6. Within normal ovarian reserve AMH(1-3) ng/ml No evidence of endometriosis.
7. No other medical or surgical diseases.

10-Careful history, general and local examination, abdominal and vaginal ultrasonography and basal haematological and chemical investigations were done

to exclude any other abnormalities which can interfere with the result of the current study.

Exclusion Criteria

1. Women older than 35 years of age or younger than 20 years old
2. Women with polycystic ovary syndrome PCOS (as defined according to the Rotterdam criteria)
3. Women who were diagnosed to have endometriosis within the last 1 year.
4. Women with ovarian hyper stimulation syndrome (OHSS).
5. Sever male factor infertility with immotile sperm which may affect embryo development
6. poor responder patient .

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes