Invitro Fertilizaion Clinical Trial
Official title:
Prediction of Metaphase II Oocytes According to Different Levels of Serum AMH in Poor Responders Using the Antagonist Protocol
A multicentric study looked into 179 poor responders who underwent antagonist protocol in
ICSI cycles Gonadotrophines is started on day 2 with HMG until the day of HCG administration
with starting dose 300IU to 450IU,with no pretreatment with OCPs or progestogens or estrogen.
GNRH antagonist (cetrorelix 0,25mg s.c, cetrotide, serono laboratories, Aubonne Switzerland)
is given using flexible protocol, it is given when at least one follicle reaches size 14 mm
to prevent premature lutenization ,until the day of hCG administration Ovarian ultrasound
scans were performed using a 5.0-9.0 MHZ multi frequency trans vaginal probe to assess the
ovarian response till the mature follicles reach18-20mm when hCG administration 10000 IU is
given to induce final oocytes maturation , serum E2 is done on day of HCG trigger.
Trans vaginal ultrasound-guided oocyte retrieval is performed 34-36 hours after hCG
injection.
Ultrasound -guided fresh embryo transfer is performed on day 3 or 5 after fertilization.
Progesterone support of luteal phase was commenced on the day of ovum pick up using
prontogest 400 mg twice daily.
| Status | Recruiting |
| Enrollment | 179 |
| Est. completion date | April 2018 |
| Est. primary completion date | April 2018 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 20 Years to 45 Years |
| Eligibility |
Inclusion Criteria: - 3- On antagonist protocol 4- Poor responder according to ESHRE consensus; in which at least 2 of the following should be present: - Advanced maternal age (= 40 years old) or any other risk factor - A previous poor ovarian response (cycles cancelled or = 3 oocytes with a conventional protocol) - An abnormal ovarian reserve test (ORT); antral follicle count (AFC) < 5-7 follicles or anti-mullerian hormone (AMH) =0.5- 1.1 ng/ml NB: In the absence of advanced maternal age or abnormal ORT, two previous episodes of poor ovarian response after maximal stimulation patients are also considered poor responders according to ESHRE consensus. - Presence and Adequate visualization of both ovaries - Uterine cavity within normal anatomy Exclusion Criteria: Any factor which may affect reproductive outcome other than that the patient is a poor responder will be excluded from the study, like: 1. Severe male factor . 2. Uterine factor (eg: fibroid, polyp, Ashermann, .. etc) 3. Immunological disorder (eg: SLE, APS, … etc) 4. Thyroid or adrenal dysfunction 5. Neoplasia (especially: hypothalamic, pit, ovarian) 6. Women diagnosed with PCOS according to Rotterdam criteria 7. Hydrosalpinx that hasn't been surgically removed or ligated. 8 . Untreated hyperprolactinemia 9 . Abnormal bleeding disorder 10.Hepatic or renal dysfunction 11.Hypersenstivity to study medication ( GNRH antagonist) 12.Need to take medication that can influence ovarian stimulation 13.Endometriosis grade 3 or 4 14.Ovarian cyst> 10 cm. |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Kasr Alainy medical school | Cairo |
| Lead Sponsor | Collaborator |
|---|---|
| Cairo University |
Egypt,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of the retrieved oocytes | number of oocytes retrieved 34 hours after HCG injection | 34 hours after HCG injection |