Clinical trial: The Impact of Body Weight on Reproductive Outcomes in Poor Ovarian Responders in ICSI Cycles (NCT03457233)

Eligibility criteria:
Inclusion Criteria:

          -  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 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
        assessed with HSG, hysteroscopy and TVUS

        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.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 44 Years

Patient description (medical language): A 32-year-old woman comes to the hospital with vaginal spotting.  Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal.  Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL.  Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus.

Patient description (patient's own words): I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule.

Does the patient match the trial criteria? Contradiction