Clinical Research Directory

Royal Jelly Supplementation in Unexplained Male Infertility

This randomized, double-blind, placebo-controlled clinical trial investigates the effects of oral Royal Jelly supplementation on sperm DNA fragmentation and pregnancy rates in couples with unexplained infertility. While routine semen analysis appears normal (normozoospermia) in these patients, underlying Sperm DNA Fragmentation (SDF) and oxidative stress are believed to contribute to reproductive failure. Participants will be randomized to receive either 750 mg of lyophilized Royal Jelly or a placebo daily for a period of 3 months (90 days). The study aims to evaluate whether the antioxidant properties of Royal Jelly can improve sperm chromatin integrity, reduce oxidative stress markers, and increase spontaneous pregnancy rates compared to the control group

ICSI Versus Conventional IVF in Couples With Unexplained Infertility

This multicenter, open-label, parallel-group, randomized controlled trial aims to compare the live birth rate, fertilization outcomes, other pregnancy outcomes and safety between ICSI and conventional IVF among couples with unexplained infertility in China.

Preovulatory Uterine Flushing With Saline as a Treatment for Unexplained Infertility

The purpose of this study is to determine whether preovulatory uterine flushing with physiological saline is effective in the treatment of unexplained infertility.

Varicocelectomy in Patients With Clinical Varicocele and Unexplained Infertility

This study was conducted to assess the efficacy of varicocelectomy in unexplained male infertility with clinical varicocele The primary objective was to assess the pregnancy outcomes in these group. The secondary objective was to analyses improvement in Sperm DNA fragmentation , hormonal profile and semen parameter after varicocelectomy in Unexplained infertility .

Possible Action of Resveratrol in Improving the Outcomes of IVF/ICSI in Couples With Unexplained Infertility

Based on available evidence and given the potential beneficial effects of resveratrol in folliculogenesis and in oocyte development, the investigators designed a randomized, controlled, double-blind, single-center trial, whose objective will be the comparison of biological and clinical outcomes of resveratrol supplement in women undergoing IVF/ICSI cycles for unexplained infertility. To the knowledge of the investigators, no study has been published on the potential effect of resveratrol on IVF/ICSI outcomes considering couples with this infertility diagnosis, which may be the natural target of this integrative treatment because the process of folliculogenesis and oocyte maturation cannot be routinely investigated. An alteration of these biological mechanisms could be the unrecognized cause of part of the unexplained infertility and treatment with resveratrol could result in significant clinical improvement for the patients enrolled in the study. In more details, the main objective of this randomized, placebo-controlled, double-blind, single-center trial will be the evaluation of the possible effect of resveratrol in determining a better follicle development in patients with unexplained infertility undergoing controlled ovarian stimulation (COS) for IVF/ICSI. Infertile female patients with normal ovarian reserve will be treated according to clinical practice and the difference between expected (through AFC) and retrieved oocytes will be assessed in relation to use of resveratrol.

IUI With Letrozole Versus in Natural Cycle

Rationale Intrauterine insemination (IUI) is the treatment of first choice for couples with unexplained and mild male factor infertility in many countries, but it is controversial whether ovarian stimulation improves fertility outcomes. In recent retrospectively collected data, we found that in couples with unexplained and mild male factor infertility undergoing IUI, ovarian stimulation with letrozole increased live birth rate as compared to natural cycle IUI without substantially increasing the multiple pregnancy rate. We therefore intend to perform a randomized clinical trial (RCT) on the subject in five reproductive medical centers in different cities in China. Objective To test the hypothesis that in couples with unexplained or mild male factor infertility scheduled for an IUI program ovarian stimulation with letrozole increases the live birth rate as compared to natural cycle treatment. Study design Multicenter randomized controlled trial. Study population Women diagnosed with unexplained or mild male factor infertility scheduled for treatment with IUI. Intervention Women will be randomized for ovarian stimulation with letrozole or to natural cycle IUI. In the group allocated to ovarian stimulation, women will receive oral tablets letrozole 5 mg daily from cycle day 3 for 5 days. We will treat the couples for 3 cycles, with a time horizon of 4 months. Main study parameters/endpoints Primary outcome is live birth resulting from conception within 4 months after randomization. Secondary endpoints are clinical pregnancy, multiple pregnancy, miscarriage rates, pregnancy complications, time to pregnancy leading to live birth. Nature and extent of the burden and risks associated with participation, benefit and group relatedness The strategies compared are already broadly applied in current practice. No additional risks are expected. There is no benefit for participants, but the results may benefit future infertile couples.