Clinical trial: The Effectiveness and Safety of the Prolonged Down-regulation Protocol for Controlled Ovarian Hyperstimulation (NCT03809221)

Eligibility criteria:
Inclusion Criteria:

          1. Women aged between 20 to 35 years old and with a history of infertility (fail to get
             pregnant after over one year's regular, unprotected sex), who receive IVF/ICSI for one
             of the following reasons:

             ① Tubal factor: e.g. peritubal adhesions, tubal obstruction, etc.. Patients with
             hydrosalpinx can be enrolled after salpingectomy or tubal ligation;

             ② Male factor: e.g. oligospermia, asthenozoospermia, teratozoospermia, etc.;

             ③ Unexplained infertility: patients with a history of infertility more than 1 year but
             with no specific cause for infertility (ovulation, tubal, endometrial and male
             factor), or still not get pregnant after the above-mentioned causes being removed.

          2. Women with a normal ovarian reserve according to: ①basal steroid hormone on day 2-4 of
             menstrual cycle: basal FSH≤10mIU/ml, estradiol (E2) <50pg/ml;②1.5<anti-Müllerian
             hormone (AMH)<4.0；③8≤antral follicle count (AFC) ≤15;

          3. First IVF/ICSI cycle;

          4. BMI≥18 and ≤25kg/m2;

          5. Informed consent

        Exclusion Criteria:

          1. Women with a negative reproductive history, including a history of:

             ① recurrent miscarriage: women with twice and more than twice spontaneous miscarriage,
             missed abortion, biochemical pregnancies, etc.;

             ② fetal malformation or chromosomal abnormalities;

             ③ intrauterine death.

          2. Women with a history of one side adnexectomy;

          3. Women with a poor ovarian response or diminished ovarian reserve (based on Bologna'
             criteria);

          4. Women with ovulation dysfunction;

          5. Women with PCOS (based on Rotterdam's criteria);

          6. Women with endometriosis;

          7. Women with the following uterine abnormalities: uterine malformation (unicornuate
             uterus, uterus bicornis, uterus duplex, mediastinum uterus), adenomyosis, submucosa
             myoma, intrauterine adhesion;

          8. Chromosomal abnormality for either or both of the couple;

          9. Women with contraindications for ART or pregnancy: uncontrolled diabetes mellitus,
             cardiac disease, undiagnosed liver and/or renal function, vaginal bleeding, suspected
             or a past history of cervical cancer, endometrial cancer, breast cancer, and a history
             of deep venous thrombosis, pulmonary embolism, stroke, etc.;

         10. Women who are enrolled in other clinical trials.
Female
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 35 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