How does hyalobarrier gel influence ovulation and pregnancy outcomes in women with scarring around the tubes and ovaries?

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2016
INTERVENTION: Participants are randomised to one of two groups using a computer generated random numbers table and opaque envelopes. Intervention group: Participants receive hyalobarrier get at laparoscopy. This involves having 10ml hyalobarrier applied around the operative site was applied as per manufacturer’s instruction. Control group: Participants receive no hyalobarrier gel at laparoscopy. Follow up for all participants involves hormonal profiling (Day 2/3 FSH and LH, and Day 21 progesterone) plus follicular tracking using ultrasonography at month 3 and month 6 post operatively. CONDITION: Adnexal adhesions ; Pregnancy and Childbirth ; Adnexal adhesions PRIMARY OUTCOME: Ovulatory status is measured using serum hormonal status (Day 2 FSH, LH and Day 21 progesterone) prior to the surgery and at 3 and 6 months after the surgery. Post‐operatively, the participant will also undergo a follicular tracking cycle at 3 and 6 months. SECONDARY OUTCOME: Clinical pregnancy is measured by the presence of a fetal heart at 5‐6 weeks gestation. INCLUSION CRITERIA: 1. Aged between 18‐38 2. Women were undergoing operative laparoscopy for gynaecological pathology, with possible peri‐ovarian adhesions
Epistemonikos ID: 039e1672b9502fc029c60b24f85ff6d0da5ed7c0
First added on: Aug 24, 2024