Clinical trial: Live Birth After Fresh Embryo Transfer Vs Frozen-thawed Embryo Transfer in Women With Polycystic Ovary Syndrome (NCT01841528)

Eligibility criteria:
Inclusion Criteria:

          -  Women diagnosed as PCOS according to Chinese PCOS diagnosis criteria;

          -  Women who have ≥1 years history of infertility;

          -  Women aged ≥20 and <35 years old;

          -  Women with body weight ≥40kg;

          -  Women who have at least one of the following indications for IVF or ICSI:

               1. Ovulation dysfunction and failed to become pregnant from ovulation induction
                  treatment;

               2. Tubal factors: unilateral or bilateral tubal obstruction, adhesion, unilateral or
                  bilateral Salpingectomy or tubal ligation;

               3. Male factors: oligoasthenozoospermia, obstructive azoospermia;

          -  Women who are undergoing their first cycle of IVF or ICSI;

          -  Women who retrieved oocytes number > 3;

          -  Women who are capable of giving informed consent.

        Exclusion Criteria:

          -  Women who underwent unilateral ovariectomy;

          -  Women diagnosed as uterus abnormality: malformed uterus (uterus unicorns, septate
             uterus, duplex uterus, uterus bicomis), adenomyosis, submucous myoma, intrauterine
             adhesion;

          -  Women or their partner with abnormal chromosome karyotype including chromosome
             polymorphism;

          -  Women who have experienced recurrent spontaneous abortion (including biochemical
             pregnancy abortion) more than 2 times;

          -  Women with medical condition that represent contraindication to assisted reproductive
             technology and/or pregnancy;

          -  Women who has developed severe OHSS before oocyte pick-up day;

          -  Women with retrieved oocytes number ≤3;

          -  Women who are unable to comply with the study procedures.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 34 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? 0